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

Catalog Number 2078175

Device Problems Material Separation (1562); Failure to Advance (2524)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/19/2024

Event Type  Injury  

Event Description

Medwatch- mw5151080 was received which states: the md(medical doctor) inserted a 300 cm.014 command wire through the micropuncture needle, trying to access the femoral artery.The radiopaque tip of the wire sheared off and remained in the patient's body.The md said the wire was subcutaneous and it was ok to stay there.Very calcified and tight lesion.Wire was likely angled against needle.No further action plan.Additional information was received.It was reported that during the procedure, the 0.014 command guide wire was advanced into the left proximal superficial femoral artery (sfa), attempting retrograde cannulation.In spite of adequate flow, resistance was noted during advancement and the tip of the wire separated, remaining in subcutaneous tissue.No attempts were made to retrieve the separated segment.The procedure was continued with a non-abbott guide wire advanced into the left distal external iliac artery.There was no adverse patient sequela.No additional information was provided.

Manufacturer Narrative

Product performance engineering reviewed the incident information; however, the product was not returned to abbott vascular for analysis.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review, and similar incident query was not performed because the lot number were not reported.The investigation determined the reported difficulties and subsequent patient effect appear to be related to the operational context of the procedure.In this case, it was reported that the wire was likely not coaxially aligned with the micro-puncture needle, resulting in resistance and the reported failure to advance.Manipulation of the wire when resistance was encountered likely contributed to the reported material separation (tip).The separated portion of the guide wire was not removed from the anatomy.There is no indication of a product quality issue with respect to manufacture, design, or labeling; therefore, no product-related corrective action will be implemented in this case.Attachment medwatch report number mw5151080.

• Brand Name: HI-TORQUE COMMAND 14 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 # 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: 18881624
• MDR Text Key: 337415136
• Report Number: 2024168-2024-03160
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648176685
• UDI-Public: 08717648176685
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/11/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2078175
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MICROPUNCTURE NEEDLE
• Patient Outcome(s): Other
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 51 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White