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 Failure to Advance (2524)

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

Event Date 01/14/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the device was unable to cross lesion.The 80% stenosed target lesion was located in the mildly tortuous and severely calcified left anterior descending artery.A 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was unable to cross the lesion.The device was removed intact, and the procedure was completed with a different device.No patient complications reported.However, device investigations revealed a break in the hypotube located at 15.1cm distal to the distal end of the strain relief.

Manufacturer Narrative

E1.Initial reporter address: (b)(6).Device evaluated by mfr: the device was returned for evaluation.A visual examination identified a break in the hypotube.The break was located at 15.1cm distal to the distal end of the strain relief.Further visual and tactile examinations identified that both section of the break was kinked in multiple locations no damages along the hypotube.A visual and tactile examination identified no kinks or damages on the shaft polymer extrusion.A microscopic examination of the distal identified no damages on the shaft polymer extrusion profile.A detailed microscopic examination of the balloon material identified no damages.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no damage.

• 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: 17385876
• MDR Text Key: 319842809
• Report Number: 2124215-2023-38430
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: IN
• 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
• Report Date: 07/24/2023

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 Expiration Date: 04/24/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029280028
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 07/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/25/2022
• 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 Sex: Male
• Patient Race: Asian