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

Model Number 3852

Device Problem Material Rupture (1546)

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

Event Date 04/11/2024

Event Type  malfunction  

Manufacturer Narrative

Initial reporter city: (b)(6).

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 12atm for 10 seconds.The device was removed without any problem using the normal method.The procedure was completed with another of the same device.No patient complications reported and the patient was good post procedure.

Manufacturer Narrative

E1 - initial reporter city: (b)(6).Device evaluated by mfr.: the device was returned for analysis.No issues identified with the hypotube shaft.No issues identified with the distal extrusion.A visual examination of the balloon identified a tear in the balloon at the distal section.A detailed microscopic examination of the balloon material identified a tear in the balloon proximal from the distal markerband when inflated to rate burst pressure of 12atm.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.The device could not be inflated on first attempt.The device was left soaking in the water bath and another attempt was made after this using an encore inflation unit the balloon inflated to rbp 12 atmospheres where a tear in the balloon proximal from the distal markerband was observed.The encore device was verified before and after use using the druck gauge to rbp 12 atmospheres as per instruction for use.No other damages were observed along the device.

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified right coronary artery.A 15mmx3.00mm wolverine coronary cutting balloon was selected for use.During the procedure, at first inflation, it was noted that the balloon ruptured at 12atm for 10 seconds.The device was removed without any problem using the normal method.The procedure was completed with another of the same device.No patient complications reported and the patient was good post procedure.

• 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: 19217514
• MDR Text Key: 341489617
• Report Number: 2124215-2024-26197
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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: 3852
• Device Catalogue Number: 3852
• Device Lot Number: 0032193902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2024
• Initial Date FDA Received: 04/30/2024
• Supplement Dates Manufacturer Received: 05/16/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2023
• 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