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); Difficult to Advance (2920)

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

Event Date 02/14/2024

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 moderately calcified right coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use in a tight lesion.During the procedure, it was noted that the balloon ruptured.The defect was caused by resistance at the hub of the guide catheter, in which the balloon passed through but ruptured.The procedure was completed with a different device.No patient complications were reported.

Event Description

It was reported that a balloon rupture occurred.The 90% stenosed target lesion was located in the moderately tortuous and moderately calcified right coronary artery.A 10mmx4.00mm wolverine coronary cutting balloon was selected for use in a tight lesion.During the procedure, it was noted that the balloon ruptured.The defect was caused by resistance at the hub of the guide catheter, in which the balloon passed through but ruptured.The procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.No issues identified with the hypotube shaft.The shaft polymer extrusion had no kinks or damages were identified.A visual examination of the balloon identified no damages.No issues identified during examination of the extrusion shaft.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.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 and during an attempt to inflate the balloon, a pinhole leak was identified in the balloon material.The pinhole was located over the distal markerband.

• 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: 18790567
• MDR Text Key: 337529236
• Report Number: 2124215-2024-11668
• 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: 04/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2024
• 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: 0031268010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• 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
• Treatment: GUIDE CATHETER: TERUMO HR 6FR BR; GUIDE CATHETER: TERUMO HR 6FR BR