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 Break (1069); Material Deformation (2976)

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

Event Date 07/19/2022

Event Type  malfunction  

Event Description

It was reported that shaft break occurred.The 92% stenosed, 11mmx3.0mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the delivery shaft was kinked and broke.The device was removed from the patient's body as per usual and procedure was completed with a different device.No complications reported and the patient was in stable condition after the procedure.

Event Description

It was reported that shaft break occurred.The 92% stenosed, 11mmx3.0mm target lesion was located in the moderately tortuous and moderately calcified left anterior descending artery.A 10mmx3.00mm wolverine coronary cutting balloon was selected for use.During procedure, it was noted that the delivery shaft was kinked and broke.The device was removed from the patient's body as per usual and procedure was completed with a different device.No complications reported and the patient was in stable condition after the procedure.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was received for product analysis.An incomplete device was returned for analysis as a result of a break in the hypotube.The break was located at 74.5 cm distal to the strain relief.The distal section of the break including the distal section of hypotube, the shaft polymer extrusion, balloon and tip were not returned for analysis.A microscopic examination of the break site identified that the break is consistent with a severe kink which occurred in the hypotube shaft which inevitably resulted in the break occurring.Further analysis identified multiple kinks along the returned section of hypotube.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: 15614754
• MDR Text Key: 306358735
• Report Number: 2124215-2022-41521
• 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: 11/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028454435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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: 54 YR
• Patient Sex: Male
• Patient Weight: 75 KG