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 Difficult to Remove (1528); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/15/2024

Event Type  Injury  

Event Description

It was reported that removal difficulties occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery (lcx).A 10mmx3.00mm wolverine cutting balloon was selected for use.During the procedure, after inflation with wolverine, there was resistance around the lcx entrance area and the balloon could not be recaptured.A 7f guidezilla was advanced, but it could not collect the wolverine.The tip of the guidezilla was then cut and the wolverine was able to be collected successfully.There were no patient complications reported and the patient was stable after the procedure.

Event Description

T was reported that removal difficulties occurred.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left circumflex artery (lcx).A 10mmx3.00mm wolverine cutting balloon was selected for use.During the procedure, after inflation with wolverine, there was resistance around the lcx entrance area and the balloon could not be recaptured.A 7f guidezilla was advanced, but it could not collect the wolverine.The tip of the guidezilla was then cut and the wolverine was able to be collected successfully.There were no patient complications reported and the patient was stable after the procedure.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination of the hypotube identified that a break had occurred in the hypotube at 118.4cm proximal from the port exchange.The proximal section of the break, including the hub/manifold was not returned with the device for analysis.No kinks or damages visible in the polymer shaft.No tears visible in the balloon material.A microscopic examination of the hypotube break site identified no issues with the actual hypotube which could have contributed to the break.A detailed microscopic examination of the balloon material identified no tears or pinholes in the balloon.The balloon did exhibit signs of having been inflated as there were traces of liquid inside the balloon.All blades were fully bonded on the balloon and did not exhibit any signs of damage.No damages were observed along the distal extrusion.Tip showed no signs of tip damage.A microscopic examination of the proximal and distal markerbands identified no damage.It was possible to load the device over a 0.014inch size guidewire with no resistance.

• 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: 18852544
• MDR Text Key: 337067888
• Report Number: 2124215-2024-13898
• 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: 04/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0032511681
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/06/2024
• Supplement Dates Manufacturer Received: 03/29/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/27/2023
• 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 Outcome(s): Required Intervention