MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Device Problems Difficult to Remove (1528); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/01/2023

Event Type  Injury  

Manufacturer Narrative

B3 date of event was estimated based on report of "pci was performed for the lesion in may x." "mp67-4_a case of wolverine cutting balloon blade dropout," was on a poster presentation at a conference on complications, (b)(6) 2023 in (b)(6) japan.

Event Description

It was reported that removal difficulty and a blade detachment occurred.The patient presented with chest tightness suggesting ischemic complications.Coronary angiography revealed a 99% stenosed target lesion located in the severely calcified right coronary artery.The lesion was prepared via rotablation with a 1.75 mm burr and successfully dilated with a 3.25 mm wolverine cutting balloon.However, upon removal of the balloon, resistance was encountered, and a blade detached likely due to the severe calcification of the lesion.Intravascular ultrasound (ivus) confirmed a residual object thought to be the blade.

Manufacturer Narrative

B3 date of event was estimated based on report of "pci was performed for the lesion in may x."."mp67-4_a case of wolverine cutting balloon blade dropout," was on a poster presentation at a conference on complications, saturday, (b)(6) 2023 in (b)(6).

Event Description

It was reported that removal difficulty and a blade detachment occurred.The patient presented with chest tightness suggesting ischemic complications.Coronary angiography revealed a 99% stenosed target lesion located in the severely calcified right coronary artery.The lesion was prepared via rotablation with a 1.75 mm burr and successfully dilated with a 3.25 mm wolverine cutting balloon.However, upon removal of the balloon, resistance was encountered, and a blade detached likely due to the severe calcification of the lesion.Intravascular ultrasound (ivus) confirmed a residual object thought to be the blade.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17705479
• MDR Text Key: 322924899
• Report Number: 2124215-2023-48873
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Male