MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE

Model Number	1009660J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported during removal of a ht balance middleweight universal guide wire from the dispenser hoop coil the tip was noted to be broken.There was no patient involvement and no clinically significant delay was reported.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 lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other incidents and/or complaints reported from this lot.There was no damage noted to the guide wire during the inspection prior to use.The investigation determined the reported material separation appears to be related to operational circumstances of the procedure.In this case, based on the returned analysis and the limited information provided, it is likely that during guide wire preparation, manipulation and/or inadvertent mishandling during guide wire removal from the dispenser coil, the core became kinked and separated at the hypotube.Corrosion was noted on the guide wire, and is likely a result of exposure to the elements during transit back to abbott vascular for analysis as the guide wire appeared to have been prepped.The noted teflon coating damage likely occurred during packing for return analysis.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE MIDDLEWEIGHT UNIVERSAL GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10555411
• Report Number: 2024168-2020-07836
• Device Sequence Number: 19715052
• Product Code: DQX
• UDI-Device Identifier: 08717648065866
• UDI-Public: 08717648065866
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K101011
• 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): 01/16/2021

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 Expiration Date: 01/31/2022
• Device Model Number: 1009660J
• Device Catalogue Number: 1009660J
• Device Lot Number: 0022172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/01/2020
• Initial Date Received by Manufacturer: 08/28/2020
• Supplement Date Received by Manufacturer: 12/29/2020
• Initial Report FDA Received Date: 09/18/2020
• Supplement Report FDA Received Date: 01/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1