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	Material Rupture (1546)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon contains blood inside.The procedure was completed with another of same device.No patient complications were reported.
Event or Problem Description
It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon contains blood inside.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the target lesion was located in the left anterior descending artery.The balloon catheter was already inside the patient's body when blood was noted in the inflation port; thus, the balloon was removed immediately.
Additional Manufacturer Narrative
Device evaluated by manufacturer: the device was returned for analysis.An examination of the returned device identified no issues.The balloon wings were relaxed and the whole balloon body was covered in blood.The returned device was attached to an encore inflation unit.Positive pressure was applied.The balloon could not fully inflate, pressure was being lost due to a leak in the shaft of the device.No balloon leak was observed.A visual and microscopic examination found no issue with the balloon or blades that could have potentially contributed to the complaint incident.All blades were present and fully bonded to the surface of the balloon.The tip section of the device was visually and microscopically examined, most part of the tip was covered in blood.During balloon inflation attempts, liquid was observed to be leaking from the tip.The leak was most likely due to damage on the inner extrusion.No issues were noted with its profile that may have potentially contributed to the complaint incident.The markerbands were visually and microscopically examined, and no issues were noted with the markerbands that may have potentially contributed to the complaint incident.A visual and tactile examination found no issues with the hypotube shaft of the device that may have potentially contributed to the complaint incident.A microscopic examination identified that the inner extrusion was damaged at a location around the proximal markerband (inside the balloon).The liquid that was observed to be leaking from tip was leaking from the damaged inner site and coming out through the tip.It is most likely that during the insertion of the device over the wire that the guidewire may have punctured through the inner.
Event or Problem Description
It was reported that a balloon rupture occurred.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the balloon contains blood inside.The procedure was completed with another of same device.No patient complications were reported.It was further reported that the target lesion was located in the left anterior descending artery.The balloon catheter was already inside the patient's body when blood was noted in the inflation port; thus, the balloon was removed immediately.

• 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: 9120970
• Report Number: 2134265-2019-11611
• Device Sequence Number: 2811988
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (Y/N): N
• PMA/510(K) Number: P950020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/11/2019

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: 07/05/2021
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0024064674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Initial Date Received by Manufacturer: 09/04/2019
• Supplement Date Received by Manufacturer: 09/26/2019; 10/18/2019
• Initial Report FDA Received Date: 09/25/2019
• Supplement Report FDA Received Date: 10/17/2019; 11/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1