MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOLVERINE CORONARY CUTTING BALLOON MONORAIL; CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING

Model Number 3850

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 12/27/2023

Event Type  malfunction  

Event Description

It was reported that device detachment occurred.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery (rca).A 6mm x 2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, pre-inflation was performed several times into the severely calcified lesion.When the device was checked after it was pulled outside the patient, part of the blade was found on the gauze while wiping the balloon with gauze.The blade detached outside of patient's body.The procedure was completed with an agent drug-coated balloon (dcb) device.There were no patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual, tactile, microscopic analysis were performed on the device.A visual and tactile examination identified no damages on the hypotube shaft and the shaft polymer extrusion.A visual examination identified that the balloon had been inflated.A detailed microscopic examination of the balloon material identified no damages to the balloon material.There was a build-up of solidified contrast media present inside the balloon which indicates that the balloon had been inflated.A microscopic examination of the blade segments identified the following.Blade and pad fully bonded onto the balloon.No damage observed on the first blade.For the second blade, the proximal blade segment was missing (detached) approximately 3mm.The entire blade pad was intact.Lastly, for the third blade, the entire blade segment was missing.The entire blade pad was intact.A microscopic examination of the tip section found no damage.

Event Description

It was reported that device detachment occurred.The 95% stenosed target lesion was located in the mildly tortuous and severely calcified proximal right coronary artery (rca).A 6mm x 2.50mm wolverine coronary cutting balloon was selected for use.During the procedure, pre-inflation was performed several times into the severely calcified lesion.When the device was checked after it was pulled outside the patient, part of the blade was found on the gauze while wiping the balloon with gauze.The blade detached outside of patient's body.The procedure was completed with an agent drug-coated balloon (dcb) device.There were no patient complications reported.

• 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: 18544795
• MDR Text Key: 333265068
• Report Number: 2124215-2023-74688
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/22/2024

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: 3850
• Device Catalogue Number: 3850
• Device Lot Number: 0032126587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/27/2023
• Initial Date FDA Received: 01/19/2024
• Supplement Dates Manufacturer Received: 02/16/2024
• Supplement Dates FDA Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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