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

Model Number 3851

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/12/2023

Event Type  malfunction  

Event Description

It was reported that the balloon was broken.The 90% stenosed, 10mm x 2.50mm target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was broken.The device was removed via guidecatheter and the procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and microscopic examination identified that the balloon was folded.No damage was observed along the entire balloon.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube found no issues.A visual and tactile examination of the distal extrusion identified no damage.The guidewire lumen was examined microscopically, and no damage was present.The markerbands were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.An examination of the tip section of the device identified no damage.

Event Description

It was reported that the balloon was broken.The 90% stenosed, 10mm x 2.50mm target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was broken.The device was removed via guidecatheter and the procedure was completed with another of the same device.No complications were reported and patient was stable post procedure.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16640105
• MDR Text Key: 312319815
• Report Number: 2124215-2023-13000
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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
• Device Operator: Health Professional
• Device Expiration Date: 05/24/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029472947
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 88 KG