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

Model Number	3855
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/20/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, when the balloon was inflated, it was noted that the balloon popped even before reaching 4atm and blood traveled back up into the shaft of the wolverine.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
B3 date of event: corrected from (b)(6) 2020 to (b)(6) 2020.
Event or Problem Description
It was reported that a balloon rupture occurred.A 15mmx3.50mm wolverine coronary cutting balloon was selected for use.During procedure, when the balloon was inflated, it was noted that the balloon popped even before reaching 4atm and blood traveled back up into the shaft of the wolverine.The procedure was completed with a different device.No patient complications were reported.It was further reported that the 70% stenosed lesion was located in a tortuous and mildy/moderately calcified artery.The balloon was inflated once at 3-4atm when the balloon popped.The procedure was completed with another of the same device and the patient condition was great post procedure.

• 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: 10742068
• Report Number: 2134265-2020-14875
• Device Sequence Number: 3195603
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/09/2020

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: 06/26/2022
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0025647182
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 10/27/2020
• Supplement Report FDA Received Date: 11/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1