ChoICE™ PT H7491216101J1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 08714729252535), received between Jul 24, 2023 and Oct 31, 2024 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (6 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 31, 2024Detachment of Device or Device Component; Material Deformation; Detachment of Device or Device Component; Material Deformation

  IT WAS REPORTED VIA USER MEDWATCH (B)(4) THAT THE TIP BECAME CRACKED. THE PATIENT PRESENTED FOR PERCUTANEOUS CORONARY INTERVENTION (PCI) OF THE LEFT ANTERIOR DESCENDING ARTERY. A WOLVERINE CUTTING BALLOON CATHETER WAS ADVANCED FOR DILATION. HOWEVER, AT THE END OF THE PROCEDURE, THE CUTTING BALLOON CATHETER WAS DIFFICULT TO REMOVE AND BECAME STUCK. THE BALLOON WAS EVENTUALLY REMOVED ALONG WITH THE ENTIRE SYSTEM. BOTH A 182 CM J CHOICE GUIDEWIRE AND ANOTHER UNSPECIFIED INTERVENTIONAL GUIDEWIRE WERE REMOVED WITH THE BALLOON AND BOTH WIRES WERE NOTED TO BE BENT AND CRACKED AT THE DISTAL TIP SO THAT THEY WERE ONLY PARTIALLY INTACT. THE PROCEDURE WAS COMPLETED WITH OTHER DEVICES, AND NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20577946 ↗
• InjurySep 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED VIA MEDWATCH (B)(4) THAT GUIDEWIRE DISTAL TIP DETACHMENT AND A DEVICE FRAGMENT REMAINED IN THE PATIENT. A 182CM CHOICE PT GUIDEWIRE WAS ADVANCED FOR USE. HOWEVER, DURING THE IMPLANTATION OF THE PACEMAKER, THE DISTAL TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. A SNARE WAS ATTEMPTED BUT WAS UNSUCCESSFUL LEAVING THE TIP OF THE WIRE INSIDE THE PATIENT. NO PATIENT COMPLICATIONS WERE REPORTED AND THE PATIENT WAS STABLE POST-PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 20311153 ↗
• InjuryJul 29, 2024Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT TIP DETACHMENT OCCURRED. THE PATIENT PRESENTED FOR A PACEMAKER IMPLANT. A 182 CM J CHOICE GUIDEWIRE WAS SELECTED FOR USE. HOWEVER, DURING THE PROCEDURE, THE TIP OF THE WIRE SHEARED OFF INSIDE THE PATIENT. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE BROKEN PIECE BUT WAS UNSUCCESSFUL. THE PROCEDURE WAS COMPLETED, BUT THE TIP OF THE WIRE REMAINS IN THE PATIENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19855987 ↗
• MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE AND ALMOST DETACHED FROM THE SHAFT AND THE GUIDEWIRES WERE PARTIALLY DETACHED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED FOR MULTIPLE INFLATIONS AT 14 TO 16 ATM FOR 12 TO 14 SECONDS. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON REMOVAL, THE WOLVERINE BALLOON WOULD NOT COME BACK THROUGH THE CHOICE PT FLOPPY GUIDEWIRE UPON DEFLATION. THE PHYSICIAN TRIED TO PULL DOUBLE NEGATIVE AND TOOK AN EMPTY 20CC SYRINGE AND PULLED NEGATIVE. NEITHER OF THESE TECHNIQUES WORKED. THE PHYSICIAN THEN INFLATED THE WOLVERINE TO 2 ATM AND DEFLATED BUT IT STILL WOULD NOT COME THROUGH TO THE GUIDEWIRE. THE PHYSICIAN THEN PLACED ANOTHER CHOICE PT FLOPPY GUIDEWIRE NEXT TO THE WOLVERINE WITH A 2.5MMX 12MM EMERGE BALLOON CATHETER ONTO THE WIRE. PHYSICIAN INFLATED NEXT TO THE WOLVERINE AND WAS FINALLY ABLE TO NUDGE THE BALLOON ENOUGH TO FULLY RETRACT IT OUT OF THE BODY. PHYSICIAN SAID IT WAS STILL VERY DIFFICULT TO RETRACT. UPON INVESTIGATION, IT WAS NOTED THAT THE TWO WIRES WERE BOTH FRAYED AND PARTIALLY DETACHED AND THE WOLVERINE SEEMED TO ALMOST BE DETACHED FROM THE SHAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19619115 ↗
• MalfunctionJun 26, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BALLOON WAS DIFFICULT TO REMOVE AND ALMOST DETACHED FROM THE SHAFT AND THE GUIDEWIRES WERE PARTIALLY DETACHED. THE TARGET LESION WAS LOCATED IN THE LEFT ANTERIOR DESCENDING ARTERY. THE BALLOON WAS INFLATED FOR MULTIPLE INFLATIONS AT 14 TO 16 ATM FOR 12 TO 14 SECONDS. A 15MMX3.00MM WOLVERINE CORONARY CUTTING BALLOON WAS SELECTED FOR USE. UPON REMOVAL, THE WOLVERINE BALLOON WOULD NOT COME BACK THROUGH THE CHOICE PT FLOPPY GUIDEWIRE UPON DEFLATION. THE PHYSICIAN TRIED TO PULL DOUBLE NEGATIVE AND TOOK AN EMPTY 20CC SYRINGE AND PULLED NEGATIVE. NEITHER OF THESE TECHNIQUES WORKED. THE PHYSICIAN THEN INFLATED THE WOLVERINE TO 2 ATM AND DEFLATED BUT IT STILL WOULD NOT COME THROUGH TO THE GUIDEWIRE. THE PHYSICIAN THEN PLACED ANOTHER CHOICE PT FLOPPY GUIDEWIRE NEXT TO THE WOLVERINE WITH A 2.5MMX 12MM EMERGE BALLOON CATHETER ONTO THE WIRE. PHYSICIAN INFLATED NEXT TO THE WOLVERINE AND WAS FINALLY ABLE TO NUDGE THE BALLOON ENOUGH TO FULLY RETRACT IT OUT OF THE BODY. PHYSICIAN SAID IT WAS STILL VERY DIFFICULT TO RETRACT. UPON INVESTIGATION, IT WAS NOTED THAT THE TWO WIRES WERE BOTH FRAYED AND PARTIALLY DETACHED AND THE WOLVERINE SEEMED TO ALMOST BE DETACHED FROM THE SHAF

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19618737 ↗
• InjuryJul 24, 2023Difficult to Remove; Detachment of Device or Device Component; Difficult to Remove; Detachment of Device or Device Component

  IT WAS REPORTED THAT GUIDEWIRE TIP DETACHMENT OCCURRED. THE 95% STENOSED TARGET LESION WAS LOCATED IN THE SEVERELY TORTUOUS AND SEVERELY CALCIFIED PROXIMAL RIGHT CORONARY ARTERY. A 182 CM CHOICE PT GUIDEWIRE WAS ADVANCED FOR TREATMENT. HOWEVER, UPON PUTTING THE GUIDEWIRE DOWN THE VESSEL, IT BECAME STUCK. THE PHYSICIAN ATTEMPTED TO REMOVE THE GUIDEWIRE BUT UPON PULLING THE GUIDEWIRE OUT OF THE GUIDE, IT BROKE, AND THE UNCOILED TIP OF THE GUIDEWIRE WAS LEFT IN THE PATIENT. A SNARE WAS USED IN AN UNSUCCESSFUL ATTEMPT TO REMOVE THE GUIDEWIRE FRAGMENT. THE PATIENT WAS SENT TO SURGERY TO RETRIEVE THE GUIDEWIRE TIP AND HAVE CORONARY ARTERY BYPASS GRAFT (CABG) SURGERY PERFORMED. NO PATIENT COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17376232 ↗