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 11/21/2022

Event Type  malfunction  

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified conduit segment of distal right coronary artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured vertically at the center upon first inflation at 6 atmospheres within 20 seconds.The device was removed using normal method without any problem.The patient's condition was good after the procedure.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.A visual examination of the balloon identified no visible damages.Attempted inflation but failed to inflate due to pinhole located on the mid-section of the balloon.All blades were intact within their pads and fully bonded to the balloon material.A visual and tactile examination of the hypotube identified no issues.A visual and tactile examination of shaft polymer extrusion identified no issues.Also, the markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.No other issues were identified during the product analysis.

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified conduit segment of distal right coronary artery.A 10mmx2.25mmwolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon ruptured vertically at the center upon first inflation at 6 atmospheres within 20 seconds.The device was removed using normal method without any problem.The patient's condition was good after the 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; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15889783
• MDR Text Key: 307513253
• Report Number: 2124215-2022-49166
• 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: 12/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0029103136
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2022
• 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