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 Inflation Problem (1310); Leak/Splash (1354)

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

Event Date 08/22/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 27oct2023.It was reported that the balloon could not be inflated, and a leak was noted on the tip of the balloon.The 15mm x 2.75mm target lesion was located in the mildly tortuous and moderately calcified diagonal branch of artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be fully inflated.The device was removed, and it was found that the balloon was leaking gas when it was pressurized.The leak was noted on the tip of the balloon.The procedure was completed with another of the same device.No complications were reported, and patient was stable post procedure.However, device analysis revealed that a pinhole tear existed in the balloon material.

Manufacturer Narrative

Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination identified multiple kinking along the length of the hypotube.A visual examination of the distal extrusion identified no damages.A visual examination of the balloon identified no damage.Microscopic examination of the inner/wire lumen identified no damages.A detailed microscopic examination of the balloon material identified no damages.All blades were fully bonded on the balloon and did not exhibit any signs of damage.A microscopic examination of the tip section found no issues.A microscopic examination of the proximal and distal markerbands found no issues which could potentially have contributed to the complaint.The device was attached to an encore inflation device, and when an attempt was made to inflate the balloon, a leak was identified over the distal markerband.A microscopic examination of the balloon, at the site of the leak, confirmed that a pinhole tear existed in the balloon material.The tear measured approximately.75mm and was located approximately 1mm proximal from the proximal markerband.No issues were noted with the device which could potentially have contributed to the pinhole leak.Further analysis identified unreported kinks along the hypotube.No other issues were identified during the product analysis.

• 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: 18177631
• MDR Text Key: 328626004
• Report Number: 2124215-2023-61629
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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
• Report Date: 11/20/2023

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: 0031191614
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2023
• Initial Date FDA Received: 11/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/08/2023
• 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
• Patient Weight: 65 KG