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	Difficult to Advance (2920); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.A wolverine cb mr, us 10mmx2.50mm was returned for analysis.Based on the potential root cause identified, the following attributes were examined.A visual and microscopic examination of the balloon material and markerbands identified no issues.The purple tip was noted to have detached from the device and was not returned.A visual and microscopic examination observed no damage to the blades.All blades were present and fully bonded to the balloon surface.The guidewire used by the customer was not returned for analysis.A microscopic examination identified that the inner guidewire lumen of the shaft was bunched 45mm proximal from distal end of the device.No other issues were identified with the shaft of the device.A visual and tactile examination found no issues in the hypotube.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 24apr2020.It was reported that the stylet was difficult to remove.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During preparation, the stylet was difficult to remove when the physician went to pull the stylet out tightness was felt.Subsequently, when the device was finally got it out, it almost looks like the tip of the balloon was not there.The physician was able to thread the wire to backload it, but the wire was unable to advance the through the balloon.Then, the distal area of the lumen was damaged and closed to the tip of the balloon.The procedure was completed with a different device.No patient complications reported.However, device analysis revealed purple tip detachment.

• 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: 10082554
• Report Number: 2134265-2020-05698
• Device Sequence Number: 2916945
• Product Code: NWX
• UDI-Device Identifier: 08714729888246
• UDI-Public: 08714729888246
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024851921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/24/2020
• Initial Report FDA Received Date: 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1