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 Material Rupture (1546)

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

Event Date 03/09/2024

Event Type  malfunction  

Event Description

It was reported that the balloon burst.The 90% stenosed target lesion was located in the mildly tortuous and severely calcified right coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the physician cannulated the rca with 7f jr 3.5 and wired with non boston scientific wire.Then the physician took 2mm balloon and tried to dilate the lesion.After creating a little lumen, he took the wolverine balloon and tried dilating the lesion.After moving from distal to mid part of lesion in mid rca, while inflating the balloon at 14atm, the balloon burst.They immediately took the balloon out intact and checked for any vessel damage and found everything was fine including vitals and all.They took another wolverine of the same size and dilated lesion at 11atm and then took synergy 2.75 x 38 and deployed it.Finally, they post dilated the stent with 3 x 12 nc balloon and completed the procedure.The patient was safe post procedure.

Manufacturer Narrative

E1 - initial reporter address 1: (b)(6).

• 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: 19212664
• MDR Text Key: 341420177
• Report Number: 2124215-2024-26032
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/30/2024

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: 0031360788
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/08/2024
• Initial Date FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2023
• 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: 68 YR
• Patient Sex: Male