MAUDE Adverse Event Report: ABBOTT VASCULAR HT BALANCE GUIDE WIRE

Model Number	1001780
Medical Device Problem Codes	Material Separation (1562); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received, but the investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that this was a peripheral case to treat a heavy calcified lesion in the superior femoral artery.A bmw wire was advanced however resistance was met with the guiding catheter and the distal end of the wire broke off.To remove the wire, a syringe was attached to the proximal end of the catheter and negative pressure was applied.Both the wire and the catheter were removed at the same time.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspections were performed on the returned guide wire, and the reported separation was confirmed.The reported difficulty to advance the wire through a proxy guiding catheter was unable to be confirmed due to the separation.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 which suggests a product quality issue did not contribute to the reported difficulties.The investigation determined the reported guide wire core separation appears to be related to operational circumstances of the procedure.In this case, is likely that manipulation of the wire during advancement through the heavily calcified anatomy guiding catheter, caused the wire core to kink and separate.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: HT BALANCE GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 9716967
• Report Number: 2024168-2020-01518
• Device Sequence Number: 16961471
• Product Code: DQX
• UDI-Device Identifier: 08717648013836
• UDI-Public: 08717648013836
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• 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
• Report Date (Section B): 03/25/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 1001780
• Device Catalogue Number: 1001780
• Device Lot Number: 9100471
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/12/2020
• Initial Date Received by Manufacturer: 01/30/2020
• Supplement Date Received by Manufacturer: 03/09/2020
• Initial Report FDA Received Date: 02/17/2020
• Supplement Report FDA Received Date: 03/25/2020
• 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