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

Catalog Number 1013784

Device Problems Peeled/Delaminated (1454); Difficult to Advance (2920); Material Twisted/Bent (2981)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.The device is expected to be returned for evaluation.It has not yet been received.A follow up report will be submitted with all relevant information.

Event Description

It was reported that the procedure was performed to treat a de novo lesion in the distal superficial femoral artery (sfa) with heavy calcification.A high-torque command 18 guide wire was advanced to the lesion with resistance from the anatomy.The guide wire was removed with no reported resistance in order to re-cannularize the sfa.Outside of the anatomy, the polymer of the guide wire was noted to have peeled and accordion.No polymer was left in the patient.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.

Manufacturer Narrative

(b)(4).Correction: the device was initially reported as returning for analysis, but has now been reported as not returning because it was discarded at the account.The incident information was reviewed; however, the product 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 similar incidents reported from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.In this case, based on the reported information, it is likely that as the guide wire was advanced toward the lesion, interaction/resistance was met with the heavy calcification in the anatomy resulting in the reported resistance causing the polymer to bunch.Manipulation and/or inadvertent mishandling during retraction against the anatomy or other devices used resulted in the polymer peeling.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

• 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
• MDR Report Key: 8184567
• MDR Text Key: 131168320
• Report Number: 2024168-2018-09922
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: 1013784
• Device Lot Number: 8042562
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/06/2018
• Initial Date FDA Received: 12/20/2018
• Supplement Dates Manufacturer Received: 02/04/2019
• Supplement Dates FDA Received: 02/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1