MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE COMMAND 14 GUIDE WIRE

Catalog Number 2078175

Device Problems Difficult to Remove (1528); Material Separation (1562); Difficult to Advance (2920)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 12/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.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 from this lot.In this case, as there was no damage noted to the guide wire during the inspection prior to use, the investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during advancement interaction with the guiding catheter resulted in the reported difficult to position.During removal, interaction with the completely occluded anatomy resulted in the reported difficulty to remove.Manipulation of the device and/or interaction with the anatomy and/or other devices resulted in the reported tip detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.The additional ht command guide wire referenced is being filed under a separate medwatch report number.

Event Description

It was reported that the procedure was performed to treat a completely occluded lesion in the tibial vessel.Resistance advancing a ht command es guide wire through a guiding catheter was felt.Resistance removing the guide wire was felt with the anatomy.The guide wire was removed and 3 inches of the tip were missing.The tip became embedded in the calf muscle and is not in the vessel.A second ht command es guide wire was advanced; however, resistance with the anatomy was felt.The guide wire was removed and it was noted that the black polymer jacket was peeling.The procedure was successfully completed with the deployment of an unspecified stent at an unknown location.There was no clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE COMMAND 14 GUIDE WIRE
• Type of Device: GUIDE WIRE
• Manufacturer (Section D): AV-TEMECULA-CT; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer (Section G): BARCELONETA, PUERTO RICO REG# 3005737652; abbott vascular; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: connie speck ; abbott vascular; 26531 ynez road; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 8192318
• MDR Text Key: 131298110
• Report Number: 2024168-2018-10022
• 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: K103101
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: 2078175
• Device Lot Number: 8101571
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2018
• 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: 89 YR