MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE COMMAND 18 GUIDE WIRE

Catalog Number 1013731

Device Problems Detachment Of Device Component (1104); Physical Property Issue (3008); Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/06/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspections were performed on the returned devices.The reported irregular texture was confirmed.Additionally, it was noted that there were multiple tears and wrinkles sporadically in the black polymer coating and the material at the tears was jagged.The black polymer coating was separated and only a small piece of the separated portion was returned on the core.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other similar incidents.It is likely that the noted damage to the polymer coating occurred after the first successful use and removal.The investigation determined that the reported difficulty was due to operational context.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.

Event Description

It was reported that during a procedure of the right anterior tibial artery, the command guide wire was used successfully and was removed from the anatomy without issue.After re-shaping the tip the guide wire was inserted into the introducer when the tip solder/transition point felt bulky.There was no reported adverse patient effect.A different command.014 guide wire was used in the procedure without issue.There was no reported clinically significant delay in the procedure.No additional information was provided.Return device analysis revealed the black polymer coating had multiple tears, wrinkles/bunched material, separated and detached black polymer coating material.

• Brand Name: HI-TORQUE COMMAND 18 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): ABBOTT VASCULAR, TEMECULA, CA USA REG# 2024168; 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: 7532159
• MDR Text Key: 108988193
• Report Number: 2024168-2018-03777
• 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: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 05/21/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 1013731
• Device Lot Number: 7071261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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 Age: 79 YR