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

Catalog Number 1013731

Device Problems Detachment Of Device Component (1104); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/21/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).Internal file number - (b)(4): during processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: the device was returned for analysis.The reported detachment was unable to be confirmed however there was a noted polymer separation.The reported torn polymer was able to be confirmed.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 did not indicate a lot specific quality issue.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that interaction with other devices as the guide wire was being removed resulted in the reported/noted polymer detachment/break and the reported/noted torn polymer.Based on the information reviewed, 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 the procedure was to treat non-tortuous, non-calcified, de novo lesions on both sides of the common iliac artery (cia).Non-abbott stents were implanted using a ht command 18 guide wire and the stents post-dilated with non-abbott balloons.No resistance was noted during use of the wire and when it was removed, the polymer cover was noted to be split and separated.It is unknown if any portion of the polymer coating remains in the patient.There was no reported adverse patient sequela or a clinically significant delay in the procedure.A new same size ht command 18 guide wire was used to successfully complete the procedure.No additional information was provided.

• 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: 7608068
• MDR Text Key: 111297210
• Report Number: 2024168-2018-04517
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648212130
• UDI-Public: 08717648212130
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1013731
• Device Lot Number: 7112761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2017
• 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 Outcome(s): Other