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); Failure to Advance (2524); Material Deformation (2976)

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

Event Date 05/03/2023

Event Type  malfunction  

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified that a break had occurred in the hypotube.The break was located at 21.2cm distal to the distal end of the strain relief.Further analysis identified multiple kinks along the distal section of the hypotube break.A visual and tactile examination identified no kinks or damages.A microscopic examination confirmed a break in the hypotube.Multiple hypotube kinks were observed along the hypotube.No issues were identified during a microscopic examination of the distal extrusion shaft.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A detailed microscopic examination of the balloon material identified no damages.The balloon did not exhibit any signs of having been inflated.A microscopic examination of the tip section found no damage.

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that the device could not cross and the proximal portion near the hub was kinked and broken.The 80% stenosed target lesion was located in the severely tortuous and moderately calcified proximal left anterior descending artery.A 10mmx3.50mm wolverine coronary cutting balloon was selected for use.During the procedure, while doing ptca to the fibrotic lesion, the device was tried to cross the lesion, but the device could not cross as it was very tortuous.After multiple attempts of trying to cross, the physician found that the balloon got kinked in proximal portion near to hub and got broken also.The device was removed intact and another 3.5x10 wolverine was used to complete the procedure successfully.No patient complications reported.However, device analysis revealed a break at 21.2cm distal to the distal end of the strain relief.

• 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: 18383575
• MDR Text Key: 331214490
• Report Number: 2124215-2023-73285
• 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
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• 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: 0030541457
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Race: Asian