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

Model Number	1001782-HC
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	05/18/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.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 to treat a mildly calcified and mildly tortuous lesion in the popliteal artery.An unspecified balloon was unable to advance over the 014 balanced middle weight (bmw) guide wire.It was noted that the guide wire separated and half of the wire remained in the patient anatomy.An attempt to snare the separated guide wire piece from the anatomy was made; however, it was unsuccessful.The patient was sent to surgery and the wire was successfully removed.No additional information was provided.
Additional Manufacturer Narrative
The device was received for analysis.A visual and dimensional inspections were performed on the retuned guide wire and the reported core separation was confirmed.The reported difficulty to advance was unable to be confirmed due to the core 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 with respect to manufacture, design or labeling did not contribute to the reported difficulties.The investigation determined the reported difficulty to advance and material separation appear to be related to operational circumstances of the procedure.Based on the reported information, it is likely that during advancement the balloon catheter encountered resistance with the mildly calcified and mildly tortuous anatomy causing the difficulty to advance over the guide wire.Manipulation against resistance likely caused the core to kink and separate on the distal end of the hypotube.Additionally, the reported treatments appear to be related to the operational context of the procedure as an unsuccessful attempt was made to snare out the separated portion of the guide wire and the patient was sent to surgery to remove the guide wire.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• Brand Name: ACS HI-TORQUE BALANCE MIDDLEWEIGHT 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: 10116773
• Report Number: 2024168-2020-04723
• Device Sequence Number: 16721712
• Product Code: DQX
• UDI-Device Identifier: 08717648025990
• UDI-Public: 08717648025990
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 07/30/2020

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: 06/30/2021
• Device Model Number: 1001782-HC
• Device Catalogue Number: 1001782-HC
• Device Lot Number: 9071572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/23/2020
• Initial Report FDA Received Date: 06/03/2020
• Supplement Report FDA Received Date: 07/30/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 87 YR