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

Catalog Number 1013730

Device Problems Off-Label Use (1494); Material Split, Cut or Torn (4008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).The device was not returned for analysis.It should be noted the contraindications.Torque guide wires for ptca, pta, and stents instructions for use, states: not intended for use in the cerebral vasculature or with atherectomy devices.The investigation determined the reported difficulties appear to be related to use error.It is likely that interaction/friction with the atherectomy device caused the reported damage to the polymer coating.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 incidents.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a calcified lesion in the tortuous right dorsalis pedis artery.An atherectomy device was used over the command guide wire and the polymer was torn away from the core.The guide wire was safely withdrawn through the guide catheter under fluoroscopy.A new command guide wire was used to complete the procedure.There were no adverse patient effects and there was no reported clinically significant delay in the procedure.No additional information was provided.

• Brand Name: HI-TORQUE COMMAND 18 GUIDE WIRE
• Type of Device: HI-TORQUE COMMAND 18 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: 8184285
• MDR Text Key: 131369108
• Report Number: 2024168-2018-09883
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648212123
• UDI-Public: 08717648212123
• 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: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 12/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 1013730
• Device Lot Number: 8050761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2018
• 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 Age: 82 YR
• Patient Weight: 56