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	04/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a balloon rupture had occurred.A percutaneous coronary intervention was being performed on a 99% stenosed lesion in the proximal portion of the right coronary artery.The 15mm x 3.5mm wolverine coronary cutting balloon ruptured on the first inflation after three seconds at six atmospheres.The procedure was successfully completed with a another of the same device without further issue or patient injury.
Additional Manufacturer Narrative
Device returned to manufacturer: the wolverine coronary cutting balloon was returned and analysis was completed.A visual examination identified that the balloon was not folded which indicates that the balloon was subjected to positive pressure.Blood was identified within the balloon and lumen which is evidence of a device leak.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied in an attempt to inflate the balloon.The balloon could not be inflated due to the presence of solidified media that was present within the inflation lumen.The device was soaked in a water bath at a temperature of 37 degrees celsius to help soften the media before further inflation attempts were made.The device was removed from the bath and the balloon was again attached to an inflation device subjected to positive pressure, but the investigator was still unable to inflate the device.A microscopic examination identified a balloon pinhole located approximately 1mm proximal of the distal markerband.A microscopic examination identified damage to the tip.This type of damage is consistent with excessive force being applied to the device when attempting to cross a lesion.The markerbands and blades of the device were visually and microscopically examined, and no issues were noted with the device and all blades were present and fully bonded to the balloon material.A visual and tactile examination found the hypotube to be kinked at more than one location.This type of damage is consistent with excessive force being applied to the delivery system.
Event or Problem Description
It was reported that a balloon rupture had occurred.A percutaneous coronary intervention was being performed on a 99% stenosed lesion in the proximal portion of the right coronary artery.The 15mm x 3.5mm wolverine coronary cutting balloon ruptured on the first inflation after three seconds at six atmospheres.The procedure was successfully completed with a another of the same device without further issue or patient injury.

• 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: 8571210
• Report Number: 2134265-2019-04294
• Device Sequence Number: 1537242
• Product Code: NWX
• UDI-Device Identifier: 08714729888376
• UDI-Public: 08714729888376
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2019

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: 03/07/2021
• Device Model Number: 3855
• Device Catalogue Number: 3855
• Device Lot Number: 0023459587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/09/2019
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 05/01/2019
• Supplement Report FDA Received Date: 06/28/2019
• Patient Sequence Number: 1