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

Model Number 3851

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

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

Event Date 04/03/2024

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the device could not cross the lesion.A blood reflux was noted and ruptured the balloon.The procedure was completed with another of same device.No complications were reported, and patient was stable post procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual and tactile examination identified multiple kinks along the length of the hypotube shaft.A shaft polymer extrusion identified no kinks, and the balloon identified no damages.A microscopic examination of the distal extrusion identified no damage.A detailed microscopic examination of the balloon material identified a 1mm longitudinal tear in the balloon.The tear was located at 1mm proximal from distal markerband.No issues were identified with the balloon material which could have contributed to the tear.All blades were fully bonded on the balloon and did not exhibit any signs of damage.The tip showed no signs of tip damage and the proximal and distal markerbands identified no damage.The device was attached to an encore inflation unit and during an attempt to inflate the balloon liquid leaked out through the site of the longitudinal tear.

Event Description

It was reported that a balloon rupture occurred.The 80% stenosed target lesion was located in the severely tortuous and severely calcified right coronary artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the device could not cross the lesion.A blood reflux was noted and ruptured the balloon.The procedure was completed with another of same device.No complications were reported, and patient was stable 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 CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19121989
• MDR Text Key: 340802474
• Report Number: 2124215-2024-22780
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0032541307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/03/2024
• Initial Date FDA Received: 04/16/2024
• Supplement Dates Manufacturer Received: 05/21/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2023
• 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: 72 YR
• Patient Sex: Male