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

Model Number 3852

Device Problems Inflation Problem (1310); Material Rupture (1546)

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

Event Date 10/17/2023

Event Type  malfunction  

Event Description

It was reported that a pinhole was noted in the balloon.The 90% stenosed target lesion was located in a 320 calcified left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, when the device was still outside the patient, the balloon could not inflate, and a pinhole was noted.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon identified no damages.No issues were noted on the hypotube shaft.Visual examination could not identify any kinks or damages on shaft polymer extrusion.A detailed microscopic examination of the balloon material identified a longitudinal tear 1mm distal from distal markerband.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No kinks or damages on the shaft polymer extrusion profile.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to an encore inflation device.An attempt was then made to inflate the balloon to 12atm as per, wolverine ifu, using an inflation aid attached however, pressure was unable to be maintained as inflation liquid was observed leaking from the longitudinal tear identified 1mm distal from distal markerband.Product analysis summary was that the device was inflated to rated burst pressure but couldn't hold pressure as a longitudinal tear was identified at the distal section of the balloon.No other device issues were identified during returned product analysis.

Event Description

It was reported that a pinhole was noted in the balloon.The 90% stenosed target lesion was located in a 320 calcified left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During procedure, when the device was still outside the patient, the balloon could not inflate, and a pinhole was noted.The procedure was completed with another of 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18169467
• MDR Text Key: 328532054
• Report Number: 2124215-2023-64855
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/27/2023

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 Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0030341440
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/07/2023
• Initial Date FDA Received: 11/20/2023
• Supplement Dates Manufacturer Received: 12/15/2023
• Supplement Dates FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2022
• 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: 73 YR
• Patient Sex: Male
• Patient Weight: 54 KG