MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3852

Device Problems Material Rupture (1546); Failure to Advance (2524)

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

Event Date 06/11/2023

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal left circumflex artery.A 15mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was difficult to cross lesion at the bend.When the head was in and half of the balloon was over the lesion, it was noted that a rupture occurred when the ballooning pressure was increased to 4 atm.Physician's comment was it was tight because of the blades at the bent.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that a balloon rupture occurred.The 50% stenosed target lesion was located in the mildly tortuous and mildly calcified proximal left circumflex artery.A 15mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, the device was difficult to cross lesion at the bend.When the head was in and half of the balloon was over the lesion, it was noted that a rupture occurred when the ballooning pressure was increased to 4 atm.Physician's comment was it was tight because of the blades at the bent.The procedure was completed with a different device.No patient complications were reported.It was further reported that there was no issue noted with the blade of the balloon.The device was removed using normal method without issue.

• 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: 17288211
• MDR Text Key: 318677568
• Report Number: 2124215-2023-32037
• 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: 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 Expiration Date: 06/17/2023
• Device Model Number: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0027509179
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2023
• Initial Date FDA Received: 07/10/2023
• Supplement Dates Manufacturer Received: 07/12/2023
• Supplement Dates FDA Received: 07/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/17/2021
• 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