MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

Model Number	1001780J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returning for analysis.It has not been received.A follow-up report will be submitted with all additional relevant information.Attachment: medsun mandatory and voluntary report form (b)(4).
Event or Problem Description
User facility medwatch report (b)(4) received that states: guide wire sheared off in the coronary.After multiple attempts with snare device, wire piece was able to be retrieved.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.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 from this lot.As there was no damage noted to the device during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with the anatomy/other devices and/or inadvertent mishandling resulted in the reported material separation.There is no indication of a product quality issue with respect to manufacture, design or labeling.D9, h3: device not available for evaluation.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 12499554
• Report Number: 2024168-2021-08295
• Device Sequence Number: 4111944
• Product Code: DQX
• UDI-Device Identifier: 08717648025976
• UDI-Public: 08717648025976
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K021228
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/21/2021

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: 02/28/2023
• Device Model Number: 1001780J
• Device Catalogue Number: 1001780J
• Device Lot Number: 1031271
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/24/2021
• Supplement Date Received by Manufacturer: 10/14/2021
• Initial Report FDA Received Date: 09/20/2021
• Supplement Report FDA Received Date: 10/21/2021
• 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: 77 YR