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 Break (1069)

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

Event Date 04/03/2023

Event Type  malfunction  

Event Description

It was reported that a shaft fracture occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified mid right coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured during advancement before reaching the lesion.The device was removed directly along the guidewire and the procedure was completed with another of the same device.No complications reported and the patient is stable.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.The following attributes were examined; a visual examination of the balloon identified no damages.A hypotube break was identified, 63.5cm distal to the distal end of the strain relief and multiple hypotube kinks along the shaft of the device.No kinks or damages are noted on shaft polymer extrusion.Microscopic analysis revealed that a detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No issues identified during examination of the extrusion shaft.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal marker bands identified no damage.

Event Description

It was reported that a shaft fracture occurred.The 80% stenosed target lesion was located in the mildly tortuous and mildly calcified mid right coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the delivery shaft was fractured during advancement before reaching the lesion.The device was removed directly along the guidewire and the procedure was completed with another of the same device.No complications reported and the patient is stable.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 16792073
• MDR Text Key: 313812358
• Report Number: 2124215-2023-18458
• 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: 07/17/2023

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 Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0030538175
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/07/2023
• Initial Date FDA Received: 04/21/2023
• Supplement Dates Manufacturer Received: 07/14/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 60 KG