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 Entrapment of Device (1212)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the device got stuck with the guidewire.The target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device got stuck with the guidewire.The catheter and the guidewire removed as a single unit and the procedure was completed with another of the same device.There were no patient complications reported.

Manufacturer Narrative

E1: initial reporter city (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual and microscopic examination of the balloon found no tears or holes in the balloon material.The balloon was folded.No damage was observed to any of the blades.All blades are fully bonded onto the balloon.A visual, microscopic and tactile examination found multiple kinks along the length of the hypotube.An examination of the distal extrusion/wire lumen identified no damages.The markerbands and tip and of the device were visually and microscopically examined, and no issues were noted with the device that may have potentially contributed to the complaint incident.Using a recommended 0.014inch size guidewire, the wire was inserted through the wire lumen with no resistance noted.It is noted that the guidewire which was used during the procedure was not returned with this device.

Event Description

It was reported that the device got stuck with the guidewire.The target lesion was located in the severely tortuous and moderately calcified left anterior descending artery.A 10mmx2.75mm wolverine coronary cutting balloon was selected for use.During the procedure, it was noted that the device got stuck with the guidewire.The catheter and the guidewire removed as a single unit and the procedure was completed with another of the same 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; 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: 13830436
• MDR Text Key: 287585063
• Report Number: 2134265-2022-03135
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/22/2022
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0026555803
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2020
• 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
• Treatment: GUIDEWIRE-SION BLUE; GUIDEWIRE-SION BLUE