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 Break (1069); Entrapment of Device (1212)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that the device got broken.An 10mmx3.25mm wolverine coronary cutting balloon monorail was selected for use.During the procedure outside the patient, it was noted that the device became stuck on the non-bsc wire and broke when trying to remove.The procedure was completed with the same wire and a different balloon.No complications were reported and the patient's status was good.

Manufacturer Narrative

E1 initial reporter city: (b)(6).Device evaluated by manufacturer: the device was returned for analysis.A visual examination identified that the balloon of the device had not been subjected to positive pressure.An examination of the balloon material, tip and markerbands identified no issues which could potentially have contributed to this complaint.A visual and microscopic examination observed no damage to the tip or blades.All blades were present and fully bonded to the balloon surface.The device placed in a 37-degree bath to soften a dried white medium that was present in the wire lumen.This wolverine device is recommended for use with a 0.014 (0.36mm) guidewire as per wolverine directions for use (dfu).The device was removed from the bath and was unable to load a boston scientific 0.014" guidewire due to damage to the guidewire lumen.A microscopic examination identified that the inner guidewire lumen of the shaft was twisted/damaged starting 45mm proximal from distal end of the tip and extending 4mm distally.No other issues were identified with the shaft of the device.A visual and tactile examination found the hypotube of the returned device to be kinked at more than one location.

Event Description

It was reported that the device got broken.An 10mmx3.25mm wolverine coronary cutting balloon monorail was selected for use.During the procedure outside the patient, it was noted that the device became stuck on the non-bsc wire and broke when trying to remove.The procedure was completed with the same wire and a different balloon.No complications were reported and the patient's status was good.

• 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
• MDR Report Key: 9438682
• MDR Text Key: 169920438
• Report Number: 2134265-2019-15250
• Device Sequence Number: 1
• Product Code: NWX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 03/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/08/2020
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0022766685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2020
• Date Manufacturer Received: 02/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1