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

Model Number UNK942

Device Problem Difficult to Remove (1528)

Patient Problem Intimal Dissection (1333)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Device evaluated by mfr: it is indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.(b)(4).

Event Description

It was reported that there was difficulty removing the balloon from the lesion and a vessel dissection occurred.A wolverine¿ coronary cutting balloon® was used to dilate a lesion and upon removal, the balloon stuck and was difficult to retrieve the balloon out of the artery.The patient had experienced a vessel dissection and was sent to surgery.The patient status was okay.

Manufacturer Narrative

(b)(4).

Event Description

It was further reported that the physician tried to advance the wolverine to the lesion but was unsuccessful so he brought the balloon back and in that process he became stuck at a 90 degree angle that he was able to advance past without difficulty.At this point he pulled on the balloon and this was what caused the dissection.The wolverine was removed and then he continued to try to repair the dissection by stenting the area but did not have a satisfactory outcome with stenting.Therefore he balloon pumped the patient and shipped them out for coronary artery bypass graft (cabg) surgery.The wolverine was never actually deployed in the vessel.

• Brand Name: WOLVERINE¿ CORONARY CUTTING BALLOON®
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7763551
• MDR Text Key: 116445948
• Report Number: 2134265-2018-07173
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• PMA/PMN Number: P950020/S072
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK942
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/18/2018
• Initial Date FDA Received: 08/08/2018
• Supplement Dates Manufacturer Received: 09/11/2018
• Supplement Dates FDA Received: 10/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention