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

Model Number 3850

Device Problem Material Rupture (1546)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address 1: (b)(6).

Event Description

It was reported that a balloon rupture occurred.The 80-85% stenosed target lesion was located in the mildly tortuous and calcified left anterior descending artery (lad) and left circumflex artery (lcx).A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured upon first inflation at low-pressure dilation.The device was simply withdrawn, and the procedure was completed with another of the same device.There were no patient complications reported post procedure.

Event Description

It was reported that a balloon rupture occurred.The 80-85% stenosed target lesion was located in the mildly tortuous and calcified left anterior descending artery (lad) and left circumflex artery (lcx).A 6mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon was ruptured upon first inflation at low-pressure dilation.The device was simply withdrawn, and the procedure was completed with another of the same device.There were no patient complications reported post procedure.

Manufacturer Narrative

E1.Initial reporter address 1: (b)(6) hospital the device was returned and evaluated by manufacturer.Multiple hypotube kinks and a break at 44.3cm distal to the distal end of the strain relief were noted along the device.No issues identified with the distal extrusion.A visual examination of the balloon identified no damages.A detailed microscopic examination of the balloon material identified no issues when inflated to rate burst pressure of 12atm and post inflation.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 markerbands identified no damage.As a result of the break in the hypotube an inflation aid was attached to the distal break site on the hypotube and using an encore inflation unit the balloon inflated to rbp 12 atmospheres without any issues and no leaks were present.The device held pressure and deflated without issues.The encore device was verified before and after use using the druck gauge to rbp 12 atmospheres as per instruction for use.

• 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19008830
• MDR Text Key: 338993171
• Report Number: 2124215-2024-18097
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0031668248
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/22/2023
• 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: 53 YR
• Patient Sex: Female
• Patient Weight: 70 KG