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 04/12/2024

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A two 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was slowly and consciously applied than the usual balloon.At first inflation, it was noted that the balloon ruptured at 6atm within 10-15 seconds.The device was removed using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.

Event Description

It was reported that a balloon rupture occurred.The target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A two 10mmx2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was slowly and consciously applied than the usual balloon.At first inflation, it was noted that the balloon ruptured at 6atm within 10-15 seconds.The device was removed using normal method without any problem.The procedure was completed with a different device.No complications were reported, and patient was good post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual and tactile was performed on hypotube shaft profile and shaft polymer extrusion with no issues were identified.Microscopic examination of the balloon identified in the proximal end of the balloon when inflating to rated burst pressure.All blades were fully bonded on the balloon and did not exhibit any signs of damage.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was attached to an encore inflation unit.A leak was located in the proximal section of the balloon when inflating to rated burst pressure of 12 atmospheres.The encore device was verified before and after use using the druck gauge.

• 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: 19210155
• MDR Text Key: 341359616
• Report Number: 2124215-2024-25722
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/21/2024

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: 0033175289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2024
• Initial Date FDA Received: 04/29/2024
• Supplement Dates Manufacturer Received: 05/10/2024
• Supplement Dates FDA Received: 05/21/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2024
• 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