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

Model Number	3854
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2021
Type of Reportable Event	Death
Event or Problem Description
It was reported that stuck in stent, shaft break, and death occurred.On an unspecified date, a non-boston scientific stent was implanted in the left anterior descending artery (lad).About a month later, the patient presented with an under-expanded stent located in the moderately tortuous and severely calcified lad.The physician decided to use a 10mmx3.00mm wolverine coronary cutting balloon to laser and then expand the stent at high pressure.When the cutting balloon was inflated past burst pressure to 15 atm, the balloon got stuck in the old stent and when the physician pulled the device back, the shaft snapped about 20cm from the hub.The device fragment was removed with a snare but the implanted stent had been deformed.A wire was unable to pass through the deformed stent for further intervention so the procedure was cancelled.The patient was stable post procedure but died the next day.
Additional Manufacturer Narrative
The device was returned for analysis.A visual and microscopic examination of the balloon identified a 5mm long tear in the balloon material.No other damage was identified along the length of the balloon.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual examination of the extrusion shaft found that a break had occurred in the midshaft extrusion.The proximal section of the break, including the hypotube and hub catheter was not returned for analysis.An examination of the break site found evidence of excessive tensile force, as the midshaft was stretched.An examination of the inner and outer extrusions, proximal to the balloon , identified some bunching.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stuck in stent, shaft break, and death occurred.On an unspecified date, a non-boston scientific stent was implanted in the left anterior descending artery (lad).About a month later, the patient presented with an underexpanded stent located in the moderately tortuous and severely calcified lad.The physician decided to use a 10mmx3.00mm wolverine coronary cutting balloon to laser and then expand the stent at high pressure.When the cutting balloon was inflated past burst pressure to 15atm, the balloon got stuck in the old stent and when the physician pulled the device back, the shaft snapped the shaft snapped about 20cm from the hub.The device fragment was removed with a snare but the implanted stent had been deformed.A wire was unable to pass through the deformed stent for further intervention so the procedure was cancelled.The patient was stable post procedure but died the next day.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• Common Device Name: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 12790947
• Report Number: 2134265-2021-14200
• Device Sequence Number: 4788424
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 07/05/2023
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0027607645
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/26/2021
• Supplement Date Received by Manufacturer: 12/15/2021
• Initial Report FDA Received Date: 11/10/2021
• Supplement Report FDA Received Date: 12/16/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/05/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown
• Patient Race: Asian