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

Model Number 3852

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/20/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified right coronary artery.A 15mm x 3.25mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon did not inflate even once.Balloon rupture was noticed since blood flowed into the inflation device when they applied negative pressure right after inserting the device into the lesion.The device was removed from the patient's body without problems and the procedure was completed with a different device.No patient complications were reported and patient's condition was good post procedure.

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in a moderately tortuous and moderately calcified right coronary artery.A 15mmx3.25mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon did not inflate even once.Balloon rupture was noticed since blood flowed into the inflation device when they applied negative pressure right after inserting the device into the lesion.The device was removed from the patient's body without problems and the procedure was completed with a different device.No patient complications were reported and patient's condition was good post procedure.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination of the balloon and inflation lumen identified no issues.The returned device was attached to a boston scientific encore inflation unit and positive pressure was applied to inflate the balloon and liquid was observed to be leaking from a balloon pinhole located at the site of the proximal marker band.The markerbands and blades and tip section of the device were visually and microscopically examined, and no issues were noted with the markerbands, blades or tip of the device that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon material.A visual and tactile examination found no issues with the shaft of the device which may have potentially contributed to the reported incident.No shaft kinks were noted at the distal end of the tip.No other issues were identified during the product analysis.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 10924424
• MDR Text Key: 218933992
• Report Number: 2134265-2020-16679
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/11/2022
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0025501974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1