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

Model Number 3854

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 10/03/2019

Event Type  malfunction  

Manufacturer Narrative

Age at time of event: over 18 years old.

Event Description

It was reported that the catheter shaft break occurred.The target lesion was located in the moderately tortuous and severely calcified mid left anterior descending artery.A 10mmx3.0mm wolverine coronary cutting balloon was selected for use.During procedure, the balloon was advanced into the lesion.However, the balloon catheter shaft broke into half before inflation.The proximal part of the balloon catheter was then removed and a 2.5mmx16mm emerge balloon was used.Subsequently, the emerge balloon was inflated and trapped the remaining wolverine shaft inside the guide catheter and facilitated the removal of all the device component from the patient's body.The procedure was completed with a new guide catheter and a non-compliant balloon.No complications reported and patient was stable.

• Brand Name: WOLVERINE CORONARY CUTTING BALLOON
• 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 IRELAND LIMITED; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 9284051
• MDR Text Key: 168072266
• Report Number: 2134265-2019-13272
• Device Sequence Number: 1
• Product Code: NWX
• UDI-Device Identifier: 08714729888260
• UDI-Public: 08714729888260
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P950020
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/15/2019
• Device Model Number: 3854
• Device Catalogue Number: 3854
• Device Lot Number: 0021388752
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2017
• 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