Synchro SELECT SSTD215STRRecalls & reported problems

Summary

The FDA's MAUDE database contains 97 adverse event reports that list this exact device (DI 07613327508499), received between Mar 15, 2021 and Sep 15, 2026 — classified as 22 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Fracture” (57 reports).

1 FDA recall record name this device's identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Apr 18, 2024Open, Classified

   Stryker Neurovascular has observed an increased frequency of PTFE coating damage occurring on the Synchro Guidewires that may be caused by the practice of backloading the guidewire through the optional introducer accessory. This issue is limited to certain lots of the Synchro Guidewire that contain an older version of the introducer accessory. Due to variation in the manufacturing process of the supplier of the introducer accessory, certain lots of introducers have sharper than intended edges that can peel off the PTFE coating when physicians use a technique known as backloading. Users with impacted product in their inventory are cautioned not to use this backloading technique.

   Z-1940-2024 · Root cause: Component design/selection · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 97 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 15, 2026Fracture

  It was reported that during treatment of a right internal carotid artery (ICA) to middle cerebral artery (MCA) stenosis, a subject guidewire was used in conjunction with a microcatheter to establish access for stent implantation. During advancement of the subject guidewire and microcatheter to the distal ICA, the subject guidewire could not be successfully superselected or positioned. The devices were withdrawn, and it was observed that the subject guidewire tip had stretched. However, The subject guidewire was returned for analysis and was examined. During device investigation and analysis, it was discovered that the subject guidewire distal tip was broken/fractured during use. The subject device was replaced, and the procedure was completed successfully. No clinical consequences were reported to the patient due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50774723 ↗
• MalfunctionAug 27, 2026Peeled/Delaminated

  It was reported that during anterior cerebral artery aneurysms procedure, the subject guidewire was delivered through the microcatheter however, the guidewire could not reach the target site as the parent vessel was tortuous and after withdrawing and performing superselective catheterization again, it was found that the guidewire had poor torquability and again upon withdrawal of guidewire out from patient's body, the subject guidewire distal tip was noted to be frayed. The subject device was replaced, and the procedure was completed successfully. No clinical consequences were reported to the patient due to this event.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50486517 ↗
• MalfunctionAug 26, 2026Fracture

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50462577 ↗
• MalfunctionJun 26, 2026Fracture

  THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE DISTAL TIP OF THE SUBJECT DEVICE WAS BROKEN/FRACTURED DURING USE. IT WAS REPORTED THAT THE PROCEDURE WAS SUCCESSFULLY COMPLETED AS NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25637164 ↗
• MalfunctionApr 8, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR AN EMERGENCY EMBOLIZATION FOR A LEFT MIDDLE CEREBRAL ARTERY BIFURCATION ANEURYSM, THE PHYSICIAN SELECTED A SUBJECT GUIDEWIRE IN CONJUNCTION WITH A MICROCATHETER FOR THE PURPOSE OF SUPER-SELECTING THE ANEURYSM. DURING THE MANIPULATION, THE PHYSICIAN OBSERVED THAT THE TIP OF THE SUBJECT GUIDEWIRE LOST CONTROLLABILITY WITHIN THE MICROCATHETER. FLUOROSCOPIC EXAMINATION REVEALED THAT APPROXIMATELY 10 CENTIMETERS OF THE RADIOPAQUE SEGMENT AT THE SUBJECT GUIDEWIRE TIP HAD FRACTURED. WHILE RETRACTING THE ENTIRE SYSTEM, THE FRACTURED SUBJECT GUIDEWIRE TIP INADVERTENTLY FELL INTO THE PATIENT'S BODY. ULTIMATELY, THE PHYSICIAN SUCCESSFULLY EXTRACTED THE FRACTURED GUIDEWIRE USING A STENT RETRIEVER. THE PHYSICIAN CONCLUDED THE PROCEDURE IMMEDIATELY AND THE PATIENT WAS TRANSFERRED TO A HIGHER-LEVEL HOSPITAL TO CONTINUE TREATMENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24815817 ↗
• MalfunctionApr 7, 2026Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS OBSERVED THAT THE GUIDEWIRE POLY TETRA FLUORO ETHYLENE (PTFE) COATING WAS PEELING. ADDITIONALLY, THERE WAS RESISTANCE WITH USE OF GUIDEWIRE AND HAS CHALLENGES WHILE ADVANCING A CATHETER OVER IT. ALSO, THE MIDSECTION AND DISTAL END TIP OF SUBJECT GUIDEWIRE WAS KINKED/BENT. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24807857 ↗
• MalfunctionApr 6, 2026Fracture

  IT WAS REPORTED THAT WHEN THE PHYSICIAN USED A SUBJECT GUIDEWIRE TO GUIDE THE MICROCATHETER INTO PLACE THROUGH SUPER-SELECTIVE CATHETERIZATION, THE PHYSICIAN FOUND THAT THE SUBJECT GUIDEWIRE WAS STRETCHED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THE SUBJECT GUIDEWIRE WAS RETURNED FOR ANALYSIS AND THE DEVICE INVESTIGATION REVEALED THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS BROKEN/FRACTURED DURING USE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24792274 ↗
• MalfunctionMar 24, 2026Fracture

  IT WAS REPORTED THAT DURING THE PROCEDURE, TWISTING OF THE GUIDEWIRE WAS INEFFECTIVE. THE SUBJECT GUIDEWIRE WAS THEN WITHDRAWN FROM THE BODY, AND A FRACTURE AT THE TIP OF THE GUIDEWIRE WAS OBSERVED. RESISTANCE WAS ENCOUNTERED AT THE MCA (MIDDLE CEREBRAL ARTERY) M1 SEGMENT DURING THE PROCEDURE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: Insufficient Information

  MAUDE report 24674621 ↗
• MalfunctionMar 19, 2026Fracture

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THE DISTAL TIP OF THE SUBJECT GUIDEWIRE WAS NOTED TO BE STRETCHED, HAD POOR DISTAL SHAPE RETENTION AND WAS BROKEN/FRACTURED DURING USE. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24646302 ↗
• MalfunctionMar 18, 2026Peeled/Delaminated

  IT WAS REPORTED THAT DURING PREPARATION, ATTEMPTED TO INSERT THE SUBJECT GUIDEWIRE INTO A MICROCATHETER USING THE INSERTION TOOL. INSERTED THE INSERTION TOOL FROM THE PROXIMAL END OF THE GUIDEWIRE; OBSERVED THAT THE GREEN MATERIAL ON THE OUTER SURFACE OF THE GUIDEWIRE WAS PEELING OFF. THE GUIDEWIRE WAS REPLACED WITH A NEW ONE, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24634106 ↗
• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT DURING TRANSARTERIAL EMBOLIZATION (TAE) PROCEDURE, THE SUBJECT GUIDEWIRE GOT FRACTURED WITHIN A NON-STRYKER MICROCATHETER WHILE GUIDING TO THE DISTAL ANEURYSM. THE SUBJECT GUIDEWIRE WAS REMOVED WITH THE ENTIRE MICROCATHETER AND THERE WERE NO REMAINS IN THE BODY. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24633752 ↗
• MalfunctionMar 18, 2026Fracture

  IT WAS REPORTED THAT DURING TRANSARTERIAL EMBOLIZATION (TAE) PROCEDURE, THE SUBJECT GUIDEWIRE GOT FRACTURED WITHIN A NON-STRYKER MICROCATHETER WHILE GUIDING TO THE DISTAL ANEURYSM. THE SUBJECT GUIDEWIRE WAS REMOVED WITH THE ENTIRE MICROCATHETER AND THERE WERE NO REMAINS IN THE BODY. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24633751 ↗
• MalfunctionFeb 25, 2026Fracture

  IT WAS REPORTED THAT GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, AS THE TIP OF THE GUIDEWIRE REACHED THE V4 SEGMENT, WITH APPROXIMATELY 10 CM OF THE GUIDEWIRE EXTENDING BEYOND THE TIP OF THE MICROCATHETER, THE PHYSICIAN FOUND THAT THE GUIDEWIRE HAD BROKEN AT THE DISTAL END OF THE MICROCATHETER AND COULD NOT BE MANIPULATED. THE PHYSICIAN PROMPTLY ADVANCED THE MICROCATHETER FORWARD AND SUCCESSFULLY WITHDREW THE BROKEN GUIDEWIRE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24445549 ↗
• InjuryFeb 11, 2026Fracture

  IT WAS REPORTED THAT DURING A PROCEDURE FOR A MIDDLE CEREBRAL ARTERY ANEURYSM, DUE TO THE EXTREMELY TORTUOUS NATURE OF THE PATIENT'S VESSELS, THE PHYSICIAN NEEDED TO REPEATEDLY TWIST AND MANIPULATE THE SUBJECT GUIDEWIRE FOR ADJUSTMENTS. DURING THE SUPER SELECTION PROCESS, IT WAS DISCOVERED THAT THE SUBJECT GUIDEWIRE HAD FRACTURED APPROXIMATELY 10 CM FROM ITS TIP, WITH HALF REMAINING INSIDE THE VESSEL AND THE OTHER HALF INSIDE THE MICROCATHETER. THE PHYSICIAN IMMEDIATELY ADVANCED AN INTERMEDIATE CATHETER TO COVER THE MICROCATHETER, CLOSED THE DRIP INFUSION, AND USED A SYRINGE TO ASPIRATE. SUBSEQUENTLY, THE MICROCATHETER WAS WITHDRAWN FROM THE BODY, AND THE GUIDEWIRE WAS REMOVED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24316217 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT DURING THE DISSECTING ANEURYSM PROCEDURE IN THE RIGHT VERTEBRAL ARTERY (VA), AFTER THE INTERMEDIATE CATHETER WAS DELIVERED IN PLACE, THE PHYSICIAN DELIVERED A GUIDEWIRE. WHEN ROTATING THE GUIDEWIRE TO SUPER SELECTIVELY ENTER THE TRUE LUMEN OF THE ANEURYSM, THE TIP OF THE GUIDEWIRE COULD NO LONGER BE TWISTED. THE PHYSICIAN WITHDREW AND FOUND THAT THE DISTAL END OF THE GUIDEWIRE WAS FRACTURED. THE PHYSICIAN THEN SELECTED THE SUBJECT GUIDEWIRE AND CONTINUED THE TWISTING SUPER SELECTION. HOWEVER, DURING THE SUPER SELECTION PROCESS, THE TIP OF SUBJECT GUIDEWIRE ALSO COULD NOT BE TWISTED. AFTER WITHDRAWING IT FOR EXAMINATION, IT WAS FOUND THAT THE DISTAL END OF THIS SUBJECT GUIDEWIRE WAS ALSO FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310777 ↗
• MalfunctionFeb 10, 2026Fracture

  IT WAS REPORTED THAT DURING THE DISSECTING ANEURYSM PROCEDURE IN THE RIGHT VERTEBRAL ARTERY (VA), AFTER THE INTERMEDIATE CATHETER WAS DELIVERED IN PLACE, THE PHYSICIAN DELIVERED THE SUBJECT GUIDEWIRE. WHEN ROTATING THE SUBJECT GUIDEWIRE TO SUPER SELECTIVELY ENTER THE TRUE LUMEN OF THE ANEURYSM, THE TIP OF THE SUBJECT GUIDEWIRE COULD NO LONGER BE TWISTED. THE PHYSICIAN WITHDREW AND FOUND THAT THE DISTAL END OF THE GUIDEWIRE WAS FRACTURED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24310708 ↗
• MalfunctionFeb 9, 2026Fracture

  IT WAS REPORTED THAT DURING THE STENT IMPLANTATION PROCEDURE AT THE POSTERIOR COMMUNICATING SEGMENT OF THE RIGHT INTERNAL CAROTID ARTERY, POOR WALL APPOSITION WAS OBSERVED AT THE CURVED SECTION OF THE CAVERNOUS SINUS SEGMENT BY THE STENT. TO ADDRESS THIS, THE PHYSICIAN UTILIZED A PREVIOUSLY USED SUBJECT GUIDEWIRE FOR STENT "MASSAGING" IN ORDER TO IMPROVE APPOSITION. DURING THE MANIPULATION, A CHANGE IN THE SUBJECT GUIDEWIRES SHAPE WAS NOTED, AND UPON WITHDRAWAL FOR EXTERNAL INSPECTION, A SIGNIFICANT CREASE/KINK WAS DISCOVERED APPROXIMATELY 12 CM FROM THE GUIDEWIRE'S TIP, INDICATING A NEAR-FRACTURE STATE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24293182 ↗
• MalfunctionJan 17, 2026Fracture

  IT WAS REPORTED THAT DURING THROMBECTOMY PROCEDURE, WHEN THE PHYSICIAN USED THE SUBJECT GUIDEWIRE TO GUIDE THE PRO18 MICROCATHETER THROUGH THE BLOOD VESSELS, HE FOUND THAT THE GUIDEWIRE WAS DIFFICULT TO TORQUE CONTROL AND ADVANCE. AFTER WITHDRAWING IT FOR EXTERNAL INSPECTION, IT WAS DISCOVERED THAT THE COATING AT THE TIP OF THE GUIDEWIRE WAS FRACTURED. STHE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24105511 ↗
• InjuryJan 13, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE INITIAL PROCEDURE OF THE STENT IMPLANTATION WAS CONDUCTED ON (B)(6) 2025 AS THE PATIENT HAD NO LIMB HEMIPLEGIA OR APHASIA AND CRANIAL AFTER SURGERY. AFTER THE PROCEDURE, THE DIAGNOSTIC IMAGING AND MRI (MAGNETIC RESONANCE IMAGING) SHOWED TWO ACUTE LACUNAR INFARCTION FOCI IN THE LEFT SUBCORTEX SENILE CEREBRAL CHANGES LEFT MAXILLARY SINUSITIS: MILD RIGHT MASTOID INFLAMMATION POSTOPERATIVE CHANGES OF THE LEFT OCULAR LENS. THE EVENT WAS CONSIDERED AS AN ISCHEMIC STROKE LOCATED AT IPSILATERAL AND IT WAS TREATED WITH MEDICATION. ONE DAY POST PROCEDURE ON (B)(6) 2025, THE PATIENT DEVELOPED BINOCULAR DIPLOPIA AS IT WAS RESOLVED ON (B)(6) 2025. THE PATIENT RECEIVED INTRAVENOUS INFUSION OF HUMAN ALBUMIN FOR VOLUME EXPANSION. LATER, A NEW LACUNAR CEREBRAL INFARCTION WAS DETECTED BY MRI, AND EDARAVONE DEXBORNEOL WAS ADMINISTERED TO SCAVENGE FREE RADICALS. IN PHYSICIAN¿S OPINION, THE CAUSE OF THE STROKE AND BINOCULAR DIPLOPIA AS THE STENT IMPLANTATION COVERS THE OPHTHALMIC ARTERY, CAUSING A THROMBOGENIC REACTION THAT AFFECTS THE BLOOD SUPPLY OF THE CENTRAL RETINAL ARTERY AND PROBABLY ALSO RELATED TO THE GUIDEWIRE (SUBJECT DEVICE). CURRENTLY, THERE IS NO IMPAIRMENT IN DAI

  Patient problems: Ischemia Stroke; Visual Disturbances

  MAUDE report 24059998 ↗
• MalfunctionJan 9, 2026Fracture

  IT WAS REPORTED THAT DURING TESTING IN CHALLENGE SILICONE MODELS, THE HYPOTUBE OF THE SUBJECT GUIDEWIRE BROKE. THE SUBJECT GUIDEWIRE REMAINED INTACT AND DID NOT SEPARATE INTO PARTS. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24019813 ↗
• MalfunctionDec 4, 2025Fracture; Fracture

  ANALYSIS OF THE RETURNED DEVICE FOUND THAT THE SUBJECT GUIDEWIRE DISTAL TIP WAS BROKEN/FRACTURED DURING USE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT REPORTED AS A RESULT OF THIS EVENT AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23721375 ↗
• MalfunctionNov 26, 2025Fracture; Fracture

  IT WAS REPORTED THE SUBJECT GUIDEWIRE GOT FRACTURED WITHIN THE MICROCATHETER DUE TO RESISTANCE IN THE SHAFT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23658856 ↗
• MalfunctionNov 20, 2025Peeled/Delaminated; Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE AND WAS REPORTED FOR DIFFICULTY IN MANEUVERING AND ADVANCING AS PER THE PHYSICIAN INPUTS. HOWEVER, WHEN THE SUBJECT DEVICE WAS RETURNED FOR ANALYSIS, IT WAS NOTICED THAT THE DISTAL END OF THE SUBJECT DEVICE WAS KINKED AND THE POLY TETRA FLUORO ETHYLENE COATING OVER THE GUIDEWIRE WAS PEELING. THE SUBJECT DEVICE WAS REPORTED TO BE REPLACED, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23610428 ↗
• MalfunctionOct 16, 2025Peeled/Delaminated; Peeled/Delaminated

  THE GUIDEWIRE (SUBJECT DEVICE) WAS RETURNED FOR ANALYSIS, AND IT WAS DISCOVERED THAT THERE WAS SKIVING NOTED TO THE POLYTETRAFLUOROETHYLENE (PTFE) COATING TO THE PROXIMAL END OF THE GUIDEWIRE (SUBJECT DEVICE). THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23316755 ↗
• MalfunctionSep 25, 2025Peeled/Delaminated; Peeled/Delaminated

  IT WAS REPORTED THAT AFTER SHAPING THE DISTAL TIP OF SUBJECT GUIDEWIRE, WHEN THE PHYSICIAN ATTEMPTED TO INSERT THE SUBJECT GUIDEWIRE INTO THE INTRODUCER SHEATH, THE SUBJECT GUIDEWIRE ENCOUNTERED RESISTANCE WITHIN THE INTRODUCER SHEATH AND MICROCATHETER SHAFT, ALSO A WHITE THREAD-LIKE SUBSTANCE THAT RESEMBLE PEELING OF HYDROPHILIC COATING WAS FOUND. THE GUIDEWIRE WAS REPLACED WITH A NEW ONE OF THE SAME KIND, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH THE SAME MICROCATHETER. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23148606 ↗