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	Cardiac Arrest (1762); Low Blood Pressure/ Hypotension (1914); Low Cardiac Output (2501); Cardiac Perforation (2513); No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: the product was discarded by the customer; 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, this confida guidewire perforated the left ventricle.Extracorporeal membrane oxygenation (ecmo) was initiated and the perforation was repaired surgically.The valve was able to be implanted.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Additional information was received.It was reported that during use of the guidewire, the patient lost blood pressure, cardiac output and pulse.Cardiopulmonary resuscitation (cpr) was performed.The lot number of the guidewire was received and has been added.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
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: 7719784
• Report Number: 2025587-2018-01858
• Device Sequence Number: 13770446
• Product Code: DQX
• UDI-Device Identifier: 20643169583737
• UDI-Public: 20643169583737
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/02/2018

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: 03/31/2021
• Device Model Number: GWBC30
• Device Catalogue Number: GWBC30
• Device Lot Number: 91704088
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/20/2018; 08/08/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 08/27/2018; 10/02/2018
• 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: Required Intervention
• Patient Age: 82 YR