MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE HEAVYWEIGHT HC; GUIDE WIRE

Model Number	1000462HJ
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.The additional hi-torque bmw device referenced is being filed under separate medwatch report number.
Event or Problem Description
It was reported that the procedure was to treat the aortic valve.During a transcatheter aortic valve implantation, two guide wires (balance middleweight and balance heavyweight) were noted as broken in two pieces.Both devices were simply removed.Two other unspecified devices were used to successfully complete the procedure.There was no reported adverse patient effect or clinically significant delay.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire, and the reported separation was confirmed.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed since the lot number was not reported.There was no damage noted to the guide wire during the inspection prior to use.The investigation determined the reported guide wire core separation appears to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE HEAVYWEIGHT HC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9780778
• Report Number: 2024168-2020-01955
• Device Sequence Number: 16315786
• Product Code: DQX
• UDI-Device Identifier: 08717648015496
• UDI-Public: 08717648015496
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K021228
• 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
• Report Date (Section B): 03/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1000462HJ
• Device Catalogue Number: 1000462HJ
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2020
• Initial Date Received by Manufacturer: 02/10/2020
• Supplement Date Received by Manufacturer: 03/05/2020
• Initial Report FDA Received Date: 03/03/2020
• Supplement Report FDA Received Date: 03/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BALANCE MIDDLE WEIGHT GUIDE WIRE; BALANCE MIDDLE WEIGHT GUIDE WIRE