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

Catalog Number 1013777

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/21/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Concomitant products: dilatation catheter: (several) paseo 35 and 18; guide wire: glidewire advantage ; sheath: biotronik fortress 6fr.(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.

Event Description

It was reported that during a procedure to treat a de novo lesion in the proximal popliteal artery with moderate tortuosity and moderate calcification, a ht command 18 guide wire was advanced but could not cross the lesion and torqueability was zero.The guide wire could hardly be advanced and removed, due to strong resistance with the vessel and patient anatomy.A non-abbott guide wire was easy to advance and remove.There was no adverse patient effect and no clinically significant delay in the procedure.During post market evaluation of the ht command 18 guide wire in comparison to the non-abbott guide wire, the physician reported that the overall performance of the ht command guide wire was significantly worse.No additional information was provided.

Manufacturer Narrative

(b)(4).It is indicated that the device is not returning; therefore, a failure analysis of the complaint device could not be completed.The investigation determined the reported difficulties to be related to the patient anatomical conditions.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.Based on the information reviewed, there is no indication of a product quality issue with the respect to manufacturing, design, or labeling.

Manufacturer Narrative

(b)(4).Correction to investigation - the investigation was unable to determine a conclusive cause for the reported difficulties.

• 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: 5154920
• MDR Text Key: 28720995
• Report Number: 2024168-2015-06104
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K152404
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 12/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2016
• Device Catalogue Number: 1013777
• Device Lot Number: 5081261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/25/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2015
• 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