MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 14 GUIDE WIRE

Model Number	2078173
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that after unsealing the packaging and removing the command guide wire, the tip was noted to be collapsed.The core and the coils were in tact.There was no device use or patient involvement.Another command guide wire was used to complete the procedure.There was no clinically significant delay in the procedure.Returned device analysis found that the polymer coating of the wire was separated.No additional information was provided.
Additional Manufacturer Narrative
The device was received.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported deformation due to compressive stress was unable to be confirmed; however, polymer damage noted near the tip may have been inadvertently reported as a deformation.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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported and noted difficulties.In this case, analysis on the returned device was unable to confirm a tip deformation; however, polymer coating damage near the tip was noted.The polymer damage may have been inadvertently reported as a deformation.Factors that may contribute to polymer coating damage include, but are not limited to, inadvertent mishandling during unpackaging, excessive force applied to device during unpackaging, and/or interaction with the dispenser hoop or an accessory device.In this case, analysis on the returned device noted that on the distal end of the polymer separation, the polymer was folded and stretched over itself.This type of damage is consistent with the guide wire interacting with another device.Additionally, scratches on the polymer were also noted, further indicating an interaction with another device.Based on the information reported by the account, it cannot be determined what caused the damages noted on the returned device.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE COMMAND 14 GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16008612
• Report Number: 2024168-2022-12835
• Device Sequence Number: 5766847
• Product Code: DQX
• UDI-Device Identifier: 08717648176661
• UDI-Public: 08717648176661
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K122573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2023

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: 04/30/2024
• Device Model Number: 2078173
• Device Catalogue Number: 2078173
• Device Lot Number: 2050971
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 12/19/2022
• Supplement Report FDA Received Date: 01/12/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown