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 Difficult to Remove (1528); Detachment of Device or Device Component (2907)

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

Event Date 07/11/2022

Event Type  malfunction  

Event Description

It was reported that the balloon was stuck in the guiding catheter and blade was detached.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was stuck when pulled into the guiding catheter due to deflation.Subsequently, it was noted that the blade was detached from the balloon when checked outside the patient body.All the blades have been removed and the procedure was completed with a different device.No complications were reported and there were no problems with the patient's condition.

Event Description

It was reported that the balloon was stuck in the guiding catheter and blade was detached.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified left coronary artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was stuck when pulled into the guiding catheter due to deflation.Subsequently, it was noted that the blade was detached from the balloon when checked outside the patient's body.All the blades have been removed and the procedure was completed with a different device.No complications were reported and there were no problems with the patient's condition.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual examination identified that the balloon was returned in a deflated state with media present inside the balloon material.An examination of the blade identified the following: 1 blade were present and secured within its pads and on the balloon surface.1 blade detached from the balloon surface with the pad intact.1 blade with its distal edge of the proximal segment raised.A visual and tactile examination identified multiple kinks.No issues were noted with the tip of the device.A visual and microscopic examination found no issue with the marker bands.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
• 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: 15147253
• MDR Text Key: 297158993
• Report Number: 2124215-2022-28241
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 09/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/10/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029207162
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/11/2022
• 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