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

Model Number 3851

Device Problems Material Rupture (1546); Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(4).

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion area was located in a mildly tortuous and milldy calcified distal right coronary artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that the device could not pas through the lesion easily.A balloon catheter was used together and was able to insert into the lesion and inflation was done.However, he balloon ruptured at 3 atmospheres upon the first inflation.The procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1.Initial reporter city: (b)(6).

Event Description

It was reported that the balloon ruptured.The 90% stenosed target lesion area was located in a mildly tortuous and milldy calcified distal right coronary artery.A 10mmx2.00mm wolverine coronary cutting balloon was selected for use in a percutaneous coronary intervention.During the procedure, it was noted that the device could not pas through the lesion easily.A balloon catheter was used together and was able to insert into the lesion and inflation was done.However, the balloon ruptured at 3 atmospheres upon the first inflation.The procedure was completed with another of the same device.There were no patient complications reported.It was further reported that the balloon was slowly inflated for about 8 seconds prior to rupture, and the device was simply pulled out of the patient's body.

• 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: 11051249
• MDR Text Key: 223053323
• Report Number: 2134265-2020-18295
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/19/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024962707
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1