MAUDE Adverse Event Report: MEDTRONIC HEART VALVES DIVISION CONFIDA BRECKER CURVE GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GWBC30
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Death (1802); Cardiac Tamponade (2226); Cardiac Perforation (2513)
Date of Event	03/05/2018
Type of Reportable Event	Death
Additional Manufacturer Narrative
Product analysis: the product was lost; therefore, no product analysis can be performed.  conclusion: without return of the product, no definitive conclusions could be drawn regarding the clinical observation.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during the implant of a transcatheter bioprosthetic valve, the guidewire may have been pushed with too much force during implantation.The movement of the guidewire against the wall of the ventricle made a hole in the left ventricle, that caused a tamponade.Cardiopulmonary resuscitation (cpr) was performed and the procedure was converted to open heart surgery.The patient subsequently expired.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Conclusion: review of the lot history record for this device found it was built to specification and met all inspection and acceptance criteria.No issues were noted that would have impacted this event.Information received for this event indicated that the physician felt that they may have pushed too much during the implant procedure, which may have caused the guidewire to perforate the left ventricle wall.It should be noted that the confida guidewire instructions for use (ifu) warns the following: do not push, pull, or rotate the wire against resistance.If resistance is met, discontinue movement of the wire, determine the reason for resistance, and take appropriate action before continuing.Do not torque the guidewire.The confida brecker guidewire consists of a pre-formed shape of the flexible distal tip which is specifically designed to position the guidewire in the left ventricle and mitigate the variability associated with the distal tip of regular guidewires.It also eliminates the need for physicians to manually bend the guidewire during the transcatheter aortic valve replacement (tavr) procedure, or other diagnostic and interventional catheterization procedures.In terms of tavr procedures, this pre-formed shape of the flexible distal tip is designed to provide stability for a tavr delivery system tracked over the guidewire and to mitigate the risk of left ventricle perforation.In addition, cardiac perforation is a known potential patient adverse effect per the ifu.It is an effect that is highly dependent on the patient's pre-procedural condition and can occur despite a normally-functioning device or model implant procedure.Procedural images were requested, but were not received.Without images and/or a returned product for analysis, we are unable to conclusively determine the root cause for the reported perforation.However, based on the information provided, the left ventricle perforation was most likely due to user related issue in which the user pushed the guidewire too much, paired with the patient¿s frail tissue.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CONFIDA BRECKER CURVE GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• Manufacturer (Section D): MEDTRONIC HEART VALVES DIVISION; 1851 e deere ave; santa ana CA 92705
• MDR Report Key: 7375125
• Report Number: 2025587-2018-00707
• Device Sequence Number: 1710840
• Product Code: DQX
• UDI-Device Identifier: 20643169583737
• UDI-Public: 20643169583737
• Combination Product (Y/N): N
• Initial Reporter Country: DA
• PMA/510(K) Number: K132623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/08/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2019
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91702012
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/05/2018
• Supplement Date Received by Manufacturer: 03/29/2018; 06/05/2018
• Initial Report FDA Received Date: 03/27/2018
• Supplement Report FDA Received Date: 04/01/2018; 06/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 81 YR