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 Material Deformation (2976)

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

Event Date 08/11/2022

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The device was returned in two pieces there was a complete shaft break present at 25 cm distal the end of the strain relief.A visual examination identified that the balloon folds were in a wrapped state and had not been subject to positive pressure.There were no issues noted with the balloon material.All blades were securely bonded and no damage to the blades were noted.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified a multiple hypotube kinks.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

Reportable based on device analysis completed on 14dec2022.It was reported that the balloon was kinked.The target lesion was located in the severely tortuous and severely calcified artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was kinked.The device was removed from the patient intact and the procedure was completed with a different device.No patient complications were reported.However, device analysis revealed that a shaft break occurred.

• 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: 16051802
• MDR Text Key: 308007595
• Report Number: 2124215-2022-54920
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: MY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/27/2022

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: 01/17/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028694786
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/14/2022
• Initial Date FDA Received: 12/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/17/2022
• 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: 85 YR
• Patient Sex: Female
• Patient Race: Asian