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 Inflation Problem (1310)

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

Event Date 05/10/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the folds tightly wrapped - blood was visible inside the balloon material a microscopic examination of the balloon found a 1.3mm longitudinal tear over the proximal markerband.The blades of the device were visually and microscopically examined, and no issues were noted that may have potentially contributed to the complaint incident.All blades were present and fully bonded to the balloon surface.A visual and tactile examination found no issues.No issues were noted with the tip section of the device.A visual and microscopic examination found no issue with the marker bands.

Event Description

Reportable based on device analysis completed on (b)(6) 2022.It was reported that the catheter couldn't fully inflate.The 85% stenosed target lesion was located in the left anterior descending artery.A 15mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the catheter could not fully inflate after inserting into the vessel.The device was explanted and replaced.The procedure was completed with another of the same device.There were no complications reported and the patient was stable post procedure.However, device analysis revealed that balloon had a 1.3mm longitudinal tear over the proximal markerband.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15178874
• MDR Text Key: 305067258
• Report Number: 2134265-2022-08388
• 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
• Report Date: 08/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0028951466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/28/2022
• 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: 57 YR
• Patient Sex: Male
• Patient Weight: 75 KG