MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Model Number	1000463H
Medical Device Problem Codes	Difficult to Remove (1528); Material Separation (1562); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/02/2020
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 that the procedure was performed to increase the size of a central shunt near the aorta and pulmonary.A balance heavyweight hydro guide wire was advanced with a non-abbott balloon.Resistance was felt between the guide wire and balloon during removal, and the proximal core of the guide wire became bent.While outside the anatomy, the proximal core became separated, and the separated portion was simply removed to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional analysis was performed on the returned device.The separation and deformation were 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.Based on the information provided, the investigation determined the reported incident was due the circumstances of the procedure.In this case, the separation was a result of the bend to the wire on the proximal end while attempting to remove the device under resistance which likely caused be the bend to the distal core wire which may have been bent during the insertion process.There is no indication of a product quality issue with respect to manufacture, design or labeling.G4 date: based on additional information received subsequent to filing the initial mdr, the correct alert date is (b)(6) 2020.

• Brand Name: ACS HI-TORQUE BALANCE HEAVYWEIGHT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 10891807
• Report Number: 2024168-2020-09851
• Device Sequence Number: 3048658
• Product Code: DQX
• UDI-Device Identifier: 08717648015502
• UDI-Public: 08717648015502
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 01/18/2021

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: 03/31/2022
• Device Model Number: 1000463H
• Device Catalogue Number: 1000463H
• Device Lot Number: 0042271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 01/07/2021
• Initial Report FDA Received Date: 11/24/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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: MONTREAL BALLOON; MONTREAL BALLOON
• Patient Age: 2 MO
• Patient Weight: 5