PINNACLE PRECISION ACCESS SYSTEM 70-6160Recalls & reported problems

Summary

The FDA's MAUDE database contains 24 adverse event reports that list this exact device (DI 00389701010786), received between Nov 22, 2016 and Sep 21, 2026 — classified as 10 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (12 reports).

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.

Most reported problems

Recent adverse event reports

The 24 most recent of 24 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 21, 2026Unraveled Material

  Terumo received the following reported information: During a Peripheral Intervention, the wire nitinol unraveled when pulling back through the needle. Once out the physician decided to use a regular 4 French Micropuncture sheath. The patient was stable, and no wire was left in patient. The blood loss was less than 250cc.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50841250 ↗
• InjuryMar 30, 2026Break; Unraveled Material

  TERUMO MEDICAL CORPORATION RECEIVED THE FOLLOWING INFORMATION: IT WAS REPORTED THAT INTERVENTIONAL CARDIOLOGIST WAS PERFORMING AN UNKNOWN TYPE OF PROCEDURE. THE WIRE INCLUDED IN THE 6FR PRECISION ACCESS KIT UNRAVELED AND BROKE OFF IN THE PATIENT. VASCULAR SURGEON WAS NOTIFIED AND IT WAS DETERMINED WIRE FRAGMENT WAS NOT IN VESSEL AND WAS TOO RISKY TO INTERVENE. THE APPROXIMATE SIZE OF THE WIRE THAT BROKE OFF INSIDE THE PATIENT IS UNKNOWN. THE WIRE BROKE OFF AT THE ACCESS SITE. THE PATIENT REMAINED IN STABLE CONDITION. THEY STATED THAT THE WIRE FELT DIFFERENT. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. THE PROCEDURE TAKING PLACE FOR THE PATIENT AT THE TIME OF THE EVENT WAS A DIAGNOSTIC HEART CATHETERIZATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 24723977 ↗
• InjuryAug 24, 2024Break; Break

  THE USER FACILITY REPORTED AN ISSUE WITH A PINNACLE PRECISION NIT KIT DURING A VENOGRAM FOR THROMBECTOMY. THE ISSUE WAS WIRE BREAKING DURING ACCESS; THE DISTAL TIP DETACHED AND WAS IN THE ARTERY. THE DOCTOR MANAGED TO LOCATE AND RETRIEVED THE WIRE TIP. THE PATIENT REMAINED STABLE; THE PROCEDURE WAS COMPLETED WITHOUT FURTHER MEDICAL INTERVENTIONS. ADDITIONAL INFORMATION WAS RECEIVED ON 26 JUL 2024: THE PHYSICIAN SNARED THE WIRE TIP. IT IS UNKNOWN IF THERE WAS CALCIUM OR STENOSIS PRESENT. THE DOCTOR SAID THAT THE ILIAC BIFURCATION WAS VERY CALCIFIED.

  Patient problems: Foreign Body In Patient

  MAUDE report 20058140 ↗
• InjuryMay 10, 2024Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES THAT THE SHEATH FRACTURED WHILE INSIDE THE FEMORAL ARTERY. THE ATTENDING PHYSICIAN MANAGED TO SNARE THE SHEATH, THOUGH THE CAUSE OF THE BREAKAGE WAS UNCLEAR. DIAGNOSIS: SUCCESSFUL DEPLOYMENT OF THE PLANNED PFO CLOSURE DEVICE. THE PROCEDURE WAS COMPLICATED BY A SEVERED 6 FRENCH SHEATH THAT HAD EMBOLIZED TO THE LEFT PULMONARY ARTERY, WHICH WAS EVENTUALLY RETRIEVED USING A 7 FRENCH SNARE. THE PROCEDURE WAS INITIALLY INTENDED AS A PLANNED PATENT FORAMEN OVALE (PFO) CLOSURE DUE TO ACUTE CEREBROVASCULAR ACCIDENT (CVA) WITH A LIKELY PARADOXICAL EMBOLISM.

  Patient problems: Embolism/Embolus; Obstruction/Occlusion

  MAUDE report 19294416 ↗
• InjuryJul 14, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED ON 01 AUG 2023: THE PROCEDURE WAS A LEFT HEART CATHETERIZATION, SO ONLY WIRES AND CATHETERS WERE PASSED THROUGH THE SHEATH. THE PATIENT DID HAVE SOME SCARRING AROUND THE ACCESS SITE FROM PREVIOUS PROCEDURES. THERE WAS MINIMAL RESISTANCE, HOWEVER NOTHING THAT SHOULD HAVE CAUSED THE SHEATH TO SEPARATE THE WAY IT DID. THE BODY OF THE SHEATH SEEMED VERY THIN AND WEAK COMPARED TO OTHER SHEATHS WE HAVE USED PREVIOUSLY.

  Patient problems: Foreign Body In Patient

  MAUDE report 17330414 ↗
• InjuryApr 12, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE DOCTOR USED THE INVOLVED IK DEVICE TO ACCESS THE RIGHT COMMON FEMORAL ARTERY. WHILE CROSSING THE CALCIUM IN THE RFA, PHYSICIAN STATED THAT TIP OF PRECISION ACCESS KIT BROKE OFF IN CALCIUM. VASCULAR SURGERY WAS CALLED, AND THEY COUNSELED CARDIOLOGIST TO MOVE FORWARD WITH CASE. PATIENT WAS DOING WELL AND WAS NOT AFFECTED. PROCEDURE OUTCOME WAS SUCCESSFUL. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED 16 MAR 2023: THE PROCEDURE PERFORMED FOR THE PATIENT AT THE TIME THE ISSUE OCCURRED WAS LEFT HEART CATHETERIZATION (LHC). THERE WAS NO SURGICAL INTERVENTION FOR THE PATIENT. THE WIRE WAS THE COMPONENT IN THE KIT THAT BROKE OFF. THEY DO NOT PLAN TO REMOVE THE WIRE TIP THAT REMAINS IN THE CALCIUM. THERE WAS NO ALLEGATION AGAINST THE TERUMO WIRE THAT BROKE OFF; CALCIUM CAUSED THE WIRE TIP TO BREAK PER PHYSICIAN. THE PATIENT CONDITION WAS CLARIFIED AS STABLE. NO OTHER DEVICES OR EQUIPMENT USED WITH THE SUBJECT WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 16722413 ↗
• InjuryOct 19, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE PHYSICIAN ATTEMPTED TO USE THE IK DEVICE INVOLVED IN THE PATIENT'S VEIN; HOWEVER, THE WIRE WAS NOT ABLE TO ADVANCE IN PAST THE NEEDLE, THE WIRE KEPT KNUCKLING. THE PHYSICIAN ATTEMPTED TO BACK THE WIRE OUT, AND TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. IT WAS BELIEVED THAT THE TIP WAS INSIDE THE TISSUE TRACT, NOT THE VEIN. THE PATIENT WILL HAVE TO HAVE THE WIRE SURGICALLY REMOVED. THE PATIENT WAS IN STABLE CONDITION. THE EVENT OCCURRED INTRA-OPERATIVE. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2022: THE PROCEDURE PERFORMED WHEN THE TIP OF THE WIRE BROKE WAS UNKNOWN. THE WIRE TIP WAS NOT REMOVED FROM THE PATIENT. THE TIP IS IN THE SUBCUTANEOUS TISSUE. IT WAS REPORTED THAT THE PATIENT WASN'T A CANDIDATE FOR SURGERY AND EVENTUALLY WILL HAVE THE WIRE REMOVED LATER.

  Patient problems: Foreign Body In Patient

  MAUDE report 15631742 ↗
• InjuryJan 14, 2022Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT THE DOCTOR EXPERIENCED TROUBLE WHILE GETTING THE GUIDEWIRE DOWN WITH THE PINNACLE PRECISION DEVICE INVOLVED. WHEN THE DOCTOR WAS ABLE TO GET THE WIRE DOWN, A PICTURE WAS TAKEN, AND METAL FRAGMENTS WERE SEEN. THE GUIDEWIRE WAS PULLED OUT AND THE GUIDEWIRE HAD UNRAVELED. THE PATIENT WAS IN STABLE CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO EQUIPMENT OR OTHER DEVICES USED WITH THE ABOVE PRODUCT. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 23DECEMBER2021: THE PROCEDURE PERFORMED WAS A LOWER EXTREMITY ANGIOGRAPHY/REVASCULARIZATION (LE ANGIO/REVASC). A METAL FRAGMENT REMAINED IN THE PATIENT. THE PATIENT WILL BE HAVING SURGERY IN THE NEXT COUPLE OF WEEKS AND THE FRAGMENT WILL THEN BE REMOVED. THE PROCEDURE WAS COMPLETED ONCE THE WIRE WAS REMOVED. NO OTHER DEVICES WERE USED AFTER REMOVING THE UNRAVELED WIRE.

  Patient problems: Foreign Body In Patient

  MAUDE report 13261259 ↗
• MalfunctionJan 11, 2022Material Separation; Material Separation

  THE USER FACILITY REPORTED THAT THE INVOLVED PINNACLE PRECISION ACCESS SYSTEM (6FR) WIRE SHEARED WHEN THE WIRE WAS REMOVED FROM PATIENT GROIN. THE PATIENT WAS IN STABLE CONDITION. THE DIAGNOSTIC CARDIAC CATHETERIZATION PROCEDURE OUTCOME WAS SUCCESSFUL. THERE WAS NO PATIENT INJURY/MEDICAL OR SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 20DECEMBER2021: THE STAFF REPORTED THAT THE WIRE SHEARED OFF WHILE COMING OUT. NO FRAGMENTS OF THE WIRE WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13226975 ↗
• MalfunctionAug 10, 2021Difficult to Advance; Difficult to Advance

  THE USER FACILITY REPORTED THAT THE PINNACLE PRECISION ACCESS SYSTEM WAS USED DURING THE PROCEDURE. THE DOCTOR WAS HAVING TROUBLE WITH THE WIRE GOING THROUGH THE NEEDLE AND NEED TO USE A COOK COPE WIRE FOR ACCESS. THERE WAS NO PATIENT INJURY, MEDICAL/SURGICAL INTERVENTION REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 22JUL2021. THE PROCEDURE WAS AN ABDOMINAL ANGIOGRAM WITH RIGHT LOWER EXTREMITY ANGIOGRAM. THE WIRE APPEARED TO BE MISSING A COATING AND THE TIP WAS DARKER THAN USUAL. THE PATIENT'S CONDITION WAS STABLE. THE OUTCOME OF THE PROCEDURE WAS THAT THEY DID A BALLOON ANGIOPLASTY OF RIGHT SFA. ADDITIONAL INFORMATION WAS RECEIVED ON 23JUL2021. THE WIRE NEVER WENT INTO THE NEEDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12299618 ↗
• MalfunctionJul 25, 2021Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THE VALVE ON THE PRECISION SHEATH WAS LEAKING DURING THE CASE. THE PROCEDURE OUTCOME WAS SUCCESSFUL, AND NO SURGERY WAS REQUIRED. THE PATIENT WAS IN STABLE CONDITION. ADDITIONAL INFORMATION WAS RECEIVED ON 01JUL2021. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250CC. ADDITIONAL INFORMATION WAS RECEIVED ON 02JUL2021. THE CASE WAS A NEURO-DIAGNOSTIC PROCEDURE. THE CASE WAS ABLE TO BE COMPLETED SUCCESSFULLY SINCE THE BLOOD LOSS WAS NOT SEVERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12223145 ↗
• MalfunctionMay 4, 2021Material Separation; Material Separation

  A MAUDE DATABASE SEARCH CONDUCTED ON 20APR2021, FOUND MW5099837. THE EVENT DESCRIPTION STATES, "TIP OF WIRE WAS SHEARED OFF OF THE TIP DURING A PERICARDIOCENTESIS".

  Patient problems: Insufficient Information

  MAUDE report 11768910 ↗
• InjuryJul 23, 2019Break; Break

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "ACCORDING TO THE PHYSICIANS OPERATIVE REPORT, FOLLOWING THE POSITIONING OF THE 5FR. ARTERIAL SHEATH IN THE RIGHT FEMORAL ARTERY, THE PHYSICIAN NEXT ATTEMPTED TO POSITION THE VENOUS ACCESS. THE MICROPUNCTURE WIRE (THE WIRE IN QUESTION) WAS UNABLE TO ADVANCE IN THE FEMORAL VEIN. WHILE ATTEMPTING TO WITHDRAWAL THE WIRE FROM THE SITE, THE TIP OF THE WIRE GOT STUCK AT THE TIP OF THE NEEDLE, AND THEN A SMALL FRAGMENT OF THE WIRE WAS BROKEN, AND STAYED VERY LIKELY ABOVE THE VEIN UNDER THE SUBCUTANEOUS TISSUE. AN INCISION WAS MADE AND EXTENDED TO USE A SURGICAL INSTRUMENT TO GRAB THE TIP OF THE WIRE. THEY WERE ABLE TO EXTRACT MOST OF THE WIRE TIP EXCEPT FOR A SMALL FRAGMENT, WHICH WAS LYING VERY LIKELY ABOVE THE VEIN. AN ULTRASOUND WAS PERFORMED, WHICH REVEALED EVIDENCE OF WIRE FITTING IN THE INTRALUMINAL VEIN, LIKELY STUCK UNDER THE SUBCUTANEOUS TISSUE. A CONSULTATION WAS OBTAINED WITH A VASCULAR SURGEON AND DETERMINED THAT IT WAS NOT NECESSARY TO EXTRACT THE TIP AT THAT TIME. ORIGINAL PROCEDURE WAS LEFT HEART CATHETERIZATION AND LEFT VENTRICULAR ANGIOGRAM. A FORMAL CONSULTATION WAS SUBSEQUENT

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8816366 ↗
• MalfunctionFeb 13, 2019Crack; Material Deformation; Crack; Material Deformation

  THE USER FACILITY REPORTED THAT THE PRECISION SHEATH KINKED AT THE HUB UPON INSERTION AND THEN SPLIT DOWN THE SHAFT OF THE SHEATH. THE PROCEDURE BEING PERFORMED WAS A NEURO ANGIOGRAM. THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH ANOTHER SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8336743 ↗
• InjuryDec 7, 2018Failure to Advance; Physical Resistance/Sticking; Failure to Advance; Physical Resistance/Sticking

  THE USER FACILITY REPORTED THAT THE DOCTOR WAS USING A 6F PRECISION SHEATH TO GAIN RIGHT COMMON FEMORAL ARTERIAL ACCESS. THE PHYSICIAN WAS NOT USING AN ULTRASOUND. HE USED THE PRECISION NEEDLE TO GAIN ACCESS, AND AFTER HE VISUALIZED BLOOD RETURN, HE THEN INSERTED THE PRECISION NITINOL WIRE. RESISTANCE WAS ENCOUNTERED AND HE TRIED TO PUSH THROUGH TO ADVANCE THE WIRE, HOWEVER, HE WAS UNSUCCESSFUL. HE THEN REMOVED THE WIRE AND NEEDLE, AND THE WIRE WAS BENT, HOWEVER IT WAS INTACT. THE PHYSICIAN THEN ATTEMPTED ACCESS AGAIN, WITH THE SAME NEEDLE AND WIRE. HE STILL MET RESISTANCE ON INSERTING THE WIRE. WHEN HE PULLED THE WIRE BACK, THE WIRE BECAME STUCK ON THE BEVEL OF THE NEEDLE. HE PULLED HARDER ON THE WIRE AND THE WIRE BECAME UNRAVELED ON THE DISTAL END. THE BENT PORTION OF THE WIRE WAS STUCK ON THE BEVEL. THE WIRE WAS REMOVED IN ITS ENTIRETY, HOWEVER, THE DISTAL END WAS COMPLETELY UNWRAPPED. THERE WAS NO PIECE OF WIRE LEFT BEHIND OR BROKEN. A MERIT MICRO KIT WAS OPENED FOR THE WIRE TO COMPLETE GAINING ACCESS. THE REMAINDER OF PROCEDURE WAS A SUCCESS. THERE WAS NO PATIENT INJURY DUE TO THE UNRAVELED WIRE, AND THE PATIENT WAS REPORTED TO BE IN STABLE CONDITION.

  Patient problems: No Information

  MAUDE report 8142420 ↗
• MalfunctionJul 17, 2018Break; Break

  THE USER FACILITY REPORTED THAT WHILE GETTING FEMORAL ACCESS ON A LEFT HEART CATHETERIZATION (LHC), PHYSICIAN ENTERED ARTERY WITH MICRO-PUNCTURE NEEDLE AND FOLLOWED WITH 021 NITINOL WIRE. WHEN RETRACTING THE WIRE TO REDIRECT IT, WIRE BEGAN TO UNRAVEL AND STRETCH OUT. THE PHYSICIAN WAS ABLE RETRIEVE ALL OF THE WIRE AND OPEN ANOTHER PRECISION KIT TO COMPLETE THE CASE. NO PATIENT CONSEQUENCE AND LEFT HEART CATHETERIZATION (LHC) WAS SUCCESSFUL. THE CONDITION OF THE PATIENT IS STABLE. THE OUTCOME OF THE PROCEDURE WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 7/12/2018: THE PHYSICIAN WAS ABLE TO PULL THE WIRE OUT OF THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7693994 ↗
• InjuryMay 4, 2018Break; Break

  THE USER FACILITY REPORTED THE PHYSICIAN ACCESSED THE RADIAL ARTERY WITH THE SUPPLIED NEEDLE, AND HE INTRODUCED THE NITINOL WIRE THROUGH THE NEEDLE AND INTO THE ARTERY. WHEN THE PHYSICIAN REMOVED THE NEEDLE, IT WAS DISCOVERED THE NITINOL WIRE HAD COME UNWOUND AND THE DISTAL TIP BROKE OFF INTO THE ARTERY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE TIP OF THE WIRE FROM THE PATIENT'S ARTERY. THE PATIENT WAS REPORTED TO BE DOING FINE FOLLOWING THE PROCEDURE. ADDITIONAL INFORMATION WAS RECEIVED ON APRIL 19, 2018. THE EVENT OCCURRED INTRA-OPERATIVE. THERE WAS NO BLOOD LOSS REPORTED. THEY USED A SNARE WAS USED TO RETRIEVE THE BROKEN END FROM THE PATIENT'S ARTERY. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. OTHER EQUIPMENT OR OTHER DEVICES USED WITH THE DEVICE WERE: J TIP WIRE, DIAGNOSTIC CATH, AND A PIG TAIL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7488251 ↗
• MalfunctionFeb 8, 2018Break; Break

  THE USER FACILITY REPORTED THE WIRE BROKE AND CAME APART GOING THROUGH NEEDLE. THE ESTIMATED BLOOD LOSS WAS LESS THAN 250 CC. THE PROCEDURE WAS SUCCESSFUL AND THE PATIENT WAS REPORTED TO BE FINE. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 24, 2018. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE IK KIT. THE BROKEN WIRE WAS RETRIEVED.

  Patient problems: Blood Loss; No Consequences Or Impact To Patient

  MAUDE report 7251130 ↗
• MalfunctionDec 19, 2017Leak/Splash; Leak/Splash

  THE USER FACILITY REPORTED THAT THERE WAS EXCESSIVE LEAKING FROM VALVE OF PRECISION SHEATHS. IT WAS REPORTED THAT THE PATIENT WAS NOT INJURED AS A RESULT OF VALVE ISSUE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7128850 ↗
• MalfunctionNov 22, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE DILATOR BROKE AT HUB UPON FLUSHING PRIOR TO BEING USED ON THE PATIENT. THERE WAS NO PATIENT INVOLVEMENT. IT WAS REPORTED THAT THE PATIENT IS IN GOOD CONDITION. THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Patient Involvement

  MAUDE report 7053323 ↗
• MalfunctionSep 14, 2017Break; Break; Scratched Material

  THE USER FACILITY REPORTED THAT THE WIRE WAS STRIPPED" AFTER GAINING RIGHT FEMORAL ACCESS THROUGH 21G WIRE PROVIDED WITH KIT. IT WAS REPORTED THAT PATIENT INJURY DID NOT OCCUR. ADDITIONAL INFORMATION WAS RECEIVED ON 8/24/2017. IT WAS REPORTED THAT THE WIRE IS SHEARING OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6865921 ↗
• MalfunctionAug 16, 2017Break; Break

  THE USER FACILITY REPORTED THAT THE WIRE UNRAVELED DURING INSERTION INTO THE NEEDLE. THE PATIENT IS STABLE AND THE PROCEDURE OUTCOME WAS SUCCESSFUL.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6798690 ↗
• MalfunctionMay 18, 2017Detachment Of Device Component; Detachment Of Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON 5/19/17. THE DILATOR WAS REMOVED WITHOUT ISSUE. THE REMAINING PORTION WAS PARTIALLY STICKING OUT, SO I COULD PULL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6574860 ↗
• MalfunctionNov 22, 2016Material Separation; Material Separation

  THE USER FACILITY REPORTED WIRE SEPARATION. FOLLOW UP COMMUNICATION WITH THE USER FACILITY CONFIRMED THE FOLLOWING INFORMATION: THE WIRE SEPARATED FROM ITSELF; THIS EVENT OCCURRED PRIOR TO PROCEDURE; AND THE PATIENT WAS NOT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 6122470 ↗