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 Inflation Problem (1310)

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

Event Date 09/06/2023

Event Type  malfunction  

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual examination of the balloon identified no damages.A hytpoube kink was noted 84.5cm distal to the distal end of the strain relief as well as a hytpoube break noted 88cm distal to the distal end of the strain relief.Visual examination of the shaft polymer extrusion could not identify any kinks or damages.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.No issues were noted with the polymer extrusion.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.The device was soaked in the water bath at 37 degrees celsius and was attached to an encore inflation device.The balloon was inflated to 12 atmospheres as per, wolverine ifu, using an inflation aid.The encore inflation device was verified before and after the procedure using a druck gauge.

Event Description

Reportable based on device analysis completed on 02nov2023.It was reported that the balloon could not be opened.The target lesion was located in the left anterior descending artery.A 10mmx2.25mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the balloon could not be opened.The procedure was completed with another of the same device.No patient complications and the patient status is stable.Device analysis revealed that a hytpoube break noted 88cm distal to the distal end of the strain relief.

• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18134785
• MDR Text Key: 328084386
• Report Number: 2124215-2023-64078
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2023
• 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: 0031482743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/24/2023
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 65 KG