MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE COMMAND 18 GUIDE WIRE

Catalog Number 1013785

Device Problems Peeled/Delaminated (1454); Difficult to Remove (1528); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/30/2023

Event Type  Injury  

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.

Event Description

It was reported that the procedure was to treat a lesion in the left superficial femoral artery (sfa).The access site was the right common femoral artery.The hi-torque command 18 guide wire failed to cross due to the anatomy and possibly interactions with the catheters as well.There was resistance during removal.The guide wire was getting sticky and resistance was noted despite re-wetting and wiping the guide wire with heparin-saline gauze.On inspection, the coating appeared to have stripped off.Unknown if polymer or teflon coating peeled off.Another non-abbott guide wire was used to complete the procedure.There was no adverse patient effect and there was no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

A visual and dimensional inspection was performed on the returned device.The reported failure to advance and difficult to remove could not be tested due to the device condition.The reported peeled / delaminated could not be confirmed; however, it is possible that the polymer damage noted during return analysis was the damage bring reported.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 determined the reported difficulties appear to be related to the operational context of the procedure.Additionally, it is possible that portions of the separated polymer remain in the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 17769710
• MDR Text Key: 323681095
• Report Number: 2024168-2023-10202
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 1013785
• Device Lot Number: 2011062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CXI CATHETER; TERUMO NAVICROSS
• Patient Outcome(s): Other
• Patient Age: 51 YR
• Patient Sex: Male