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 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: 18 years or older.

Event Description

It was reported that balloon rupture occurred.The 75% stenosed target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 10mmx2.50mm wolverine cutting balloon was selected for use.During the procedure, the balloon ruptured in a pinhole form at the distal side upon fourth inflation at 12 atmospheres for 10 seconds.The device was removed without any issue and the procedure was completed with this device.No complications were reported and the patient was in good condition 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: 16076958
• MDR Text Key: 306503092
• Report Number: 2124215-2022-55534
• 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
• Report Date: 12/30/2022

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 Expiration Date: 02/22/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028918954
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/15/2022
• Initial Date FDA Received: 12/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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
• Treatment: GUIDE CATHETER: 6F HYPERION JL3.5.; GUIDEWIRE: SION BLUE.; INFLATION DEVICE: NIPRO.; INTRODUCER SHEATH: 6F RADIFOCUS.
• Patient Sex: Male