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

Catalog Number 1013785

Device Problem Peeled/Delaminated (1454)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/29/2023

Event Type  malfunction  

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 ht command 18 guidewire was used in an unspecified procedure with a non-abbott 4 fr guide catheter; however, during removal the polymer coating became loose [peeling] from the tip.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

The incident information was reviewed; 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 was not provided.The investigation was unable to determine a conclusive cause for the reported peeled / delaminated.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: 18426815
• MDR Text Key: 331859199
• Report Number: 2024168-2024-00006
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 02/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013785
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2024
• 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: 4.0 FR BENTLEY BEBACK CATHETER