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

Model Number	2078172
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the ht command 14 guidewire was removed from the package, a chip in the teflon was noted.It was thought that the teflon coating was chipped prior to removal of the device from the packaging.Therefore, the guidewire was not used in the patient anatomy.There was no patient involvement and no clinically significant delay in the procedure.The procedure was successfully completed with another ht command 14 guidewire.No additional information was provided.
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.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported peeled/delaminated tip was unable to be confirmed; however, it is possible that the noted polymer damage was the issue the account was referring to.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 peeled / delaminated tip.Factors that may contribute to a peeled or damaged tip after unpackaging include, but are not limited to, damage incurred during manufacturing, damage during shipping, and/or inadvertent mishandling during unpackaging.In this case, based on the information provided and the condition of the returned device, it is unknown what may have caused the reported peeled or damaged tip.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: 15491620
• Report Number: 2024168-2022-10029
• Device Sequence Number: 19312607
• Product Code: DQX
• UDI-Device Identifier: 08717648176654
• UDI-Public: 08717648176654
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/03/2023

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: 02/29/2024
• Device Model Number: 2078172
• Device Catalogue Number: 2078172
• Device Lot Number: 2031071
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/06/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 09/27/2022
• Supplement Report FDA Received Date: 02/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/10/2022
• 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