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 Difficult to Remove (1528)

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

Event Date 04/22/2022

Event Type  Injury  

Event Description

It was reported that the device was stuck in lesion.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was dilated once at 6atm within 20 seconds.However, the device got stuck in the lesion and resistance was felt during removal.The hub was cut, then device was removed successfully with a guide extension catheter.The procedure was completed with a different device.There were no further patient complications reported.

Event Description

It was reported that the device was stuck in lesion.The 90% stenosed target lesion was located in the moderately tortuous and severely calcified left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, the balloon was dilated once at 6atm within 20 seconds.However, the device got stuck in the lesion and resistance was felt during removal.The hub was cut, then device was removed successfully with a guide extension catheter.The procedure was completed with a different device.There were no further patient complications reported.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.The device was returned without its manifold/hub present.A complete break in the hypotube was noted as approximately 148cm proximal to the distal tip.A tactile examination of the hypotube identified multiple hypotube kinks.A visual and microscopic examination identified that the balloon was returned in a deflated state.The balloon had been subjected to positive pressure.3 blades were present on the balloon surface however the following blade damage was noted on one blade: blade 1: the proximal blade segment was found to be missing from its pad and not returned.No damage was noted with the pad of the blade, and it was fully adhered to the balloon material.Blade 2 and 3: no issues noted.A visual and tactile examination identified multiple kinks and stretching along the shaft polymer extrusion.An examination of the tip section identified distal tip damage.A visual and microscopic examination found no issue with the marker bands.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON MONORAIL
• Type of Device: CATHETER, PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA), CUTTING/SCORING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 14281058
• MDR Text Key: 290685026
• Report Number: 2134265-2022-05108
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/13/2022

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 Expiration Date: 03/06/2024
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0028997213
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/22/2022
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: 06/20/2022
• Supplement Dates FDA Received: 07/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2022
• 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