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 Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems No Consequences Or Impact To Patient (2199); Complaint, Ill-Defined (2331)

Event Date 03/24/2020

Event Type  malfunction  

Event Description

It was reported that a serious injury occurred on the patient.A 10mmx2.00mm wolverine coronary cutting balloon was introduced inside the patient.During the procedure, an unspecified device issue occurred and the patient experienced an injury.The procedure was completed with another of the same device.

Event Description

It was reported that a serious injury occurred on the patient.A 10mmx2.00mm wolverine coronary cutting balloon was introduced inside the patient.During the procedure, an unspecified device issue occurred and the patient experienced an injury.The procedure was completed with another of the same device.However, it was further reported that the device issue was a failure to cross the lesion.There was no adverse effect and no complications to the patient.

Manufacturer Narrative

B1: adverse event/product problem - from adverse event to product problem.B2: rfb outcome attrib to adv evnt - from required to n/a.F10: patient code - from complaint, iii defne to no consequences or impact to patient.F10: device code - from adverse event without identified device or use problem to failure to advance.H1: type of reportable event - from serious injury to malfunction.

• 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: 9968861
• MDR Text Key: 188206222
• Report Number: 2134265-2020-04360
• 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: 05/11/2020

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: 10/13/2021
• Device Model Number: 3851
• Device Catalogue Number: 3851
• Device Lot Number: 0024589053
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2020
• Initial Date FDA Received: 04/16/2020
• Supplement Dates Manufacturer Received: 04/16/2020
• Supplement Dates FDA Received: 05/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other