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

Catalog Number 1013731

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

Patient Problem Foreign Body In Patient (2687)

Event Date 02/23/2024

Event Type  Injury  

Event Description

It was reported that the procedure was to treat a lesion in the anterior tibial artery.The ht command 18 guidewire (gw) was advancing into a micro-puncture needle when the coating of the guidewire become delaminated.The coating had sheared off; however, still remained attached to the gw.The gw and micro-puncture needle had to be removed as a single unit.It was not confirmed that any coating had been left inside the patient.There was no adverse patient sequela and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

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

Manufacturer Narrative

The device was not returned for analysis.A review of the corrective and preventive actions (capa) database was performed and revealed no related complaint assessment capas.The lot history record (lhr) no associated manufacturing nonconformities issued to the reported lot.Additionally, a query of the complaint handling database for the reported lot revealed no indication of a lot specific issue.The investigation was unable to determine a conclusive cause for the reported difficulties; however, the reported patient effect is likely due to operational circumstances.In this case, it was reported that the guide wire became delaminated during advancement into the micro puncture needle.It is possible that the guide wire and the needle were not coaxially aligned with advanced into the needle, contributing to interaction between the devices and resulting in the reported peeled / delaminated wire.Damage to the wire would impact its maneuverability with the needle, possibly resulting in the reported difficulty during removal.Additionally, it was not confirmed that any coating had been left inside the patient.There is no indication of a product quality issue with respect to manufacture, design, or labeling.D9, h3 - device returning updated from returning to not returning.

• 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: 18924955
• MDR Text Key: 337917878
• Report Number: 2024168-2024-03451
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: 08717648212130
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013731
• Device Lot Number: 3112261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/27/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/22/2023
• 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
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Female
• Patient Weight: 61 KG