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

Catalog Number 1013829

Device Problems Break (1069); Difficult to Insert (1316); Material Separation (1562)

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

Event Date 12/22/2023

Event Type  malfunction  

Event Description

It was reported that the procedure was to treat a heavily calcified, mildly tortuous anterior tibial artery that is 100% stenosed.The ht command 18 guide wire tip almost separated outside of the puncture sheath when attempting to insert the guide wire as there was difficulty noted.Another guide wire was used to complete the procedure.There was no adverse patient effects reported and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

The device was not returned for analysis.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 difficulties.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

Manufacturer Narrative

A visual and dimensional analysis was performed on the returned device.The reported difficult to insert could not be tested due to the device condition.The reported break was not confirmed.The reported material separation was confirmed.A review of the electronic lot history record (lhr) revealed 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 determined the noted material separation (polymer) appears to be related to a potential product quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.H6: medical device problem code 1562 added.

Event Description

Subsequently, after the initial was filed it was noted that after the guide wire was removed it was note the polymer coating separated from the device.No polymer coating was left in the patient.No additional information was provided.

• 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: 18531213
• MDR Text Key: 333217138
• Report Number: 2024168-2024-00947
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648224379
• UDI-Public: (01)08717648224379(17)241231(10)3012661
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1013829
• Device Lot Number: 3012661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2023
• 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