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 Difficult to Remove (1528)

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

Event Date 08/31/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter facility name: (b)(6).The device was returned for evaluation.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft, no kinks or damages to the shaft polymer extrusion, and no balloon damage.The device was received with the product stylet/mandrel.The stylet/mandrel was not inserted through the wire lumen and an examination of the tip section of the device revealed the tip was detached from the balloon catheter and was positioned on the stylet/mandrel.A microscopic examination of the tip break noted that the break is consistent with excessive tensile forces being applied to the tip, resulting in the break.Microscopic examination of the distal extrusion, balloon, and blades identified no damage.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the mandrel could not be removed.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During preparation, it was noted that the mandrel used to protect the tip during shipment could not be removed.The procedure was completed with a different device.There is no patient injury reported.However, device investigations revealed that the tip was detached from the balloon catheter.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18360637
• MDR Text Key: 331200016
• Report Number: 2124215-2023-66149
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/18/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029242326
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2022
• 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