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 Code	Difficult to Advance (2920)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/01/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Date of event is an estimated date based off the aware date as the exact event date was not reported.
Event or Problem Description
It was reported that vessel dissection occurred.The chronic totally occluded (cto) target lesion was located in the right coronary artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During procedure, the stent still could not cross even after pre-dilatation.Subsequently, this balloon was tried and prepped properly.The balloon went through the lesion but it did not modify the plaque enough and the stent still could not cross.The same balloon was inserted again and went up to nominal pressure but the stent still could not be delivered.After the wire was pulled, a shot was taken and the vessel was dissected.The lesion was a cto and the vessel has retrograde filling.No further patient complications were reported.

• 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
• MDR Report Key: 10750155
• Report Number: 2134265-2020-14856
• Device Sequence Number: 3061168
• Product Code: NWX
• UDI-Device Identifier: 08714729888239
• UDI-Public: 08714729888239
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/28/2020

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: 10/17/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024620191
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 10/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention