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

Catalog Number 22317HS-901

Device Problems Difficult To Position (1467); Difficult to Remove (1528); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer reported the device was discarded.Investigation is not yet complete.A follow up report will be submitted with all relevant information.The other four hi-torque intermediate guide wires referenced are filed under separate manufacturing report numbers.

Event Description

It was reported that during a procedure of the mildly calcified, non-tortuous, right coronary artery (rca) a hi-torque intermediate guide wire was used with a 2.5 x 15 mm trek otw balloon dilatation catheter (bdc).The guide wire movement was sluggish and sticky.The guide wire was removed, flushed and wiped down, but attempts to advance the guide wire remained sluggish and sticky.The wire was not stuck or frozen.The guide wire was removed from the bdc and the anatomy, and replaced four additional times with a new hi-torque intermediate guide wire, with the same result.A balance middleweight universal ii (bmwuii) guide wire was successfully used to complete the procedure without issue.There was no reported adverse patient effect and no clinically significant delay in the procedure.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 was unable to determine a conclusive cause for the reported difficulties.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.Five unused, sterile hi-torque intermediate guide wires with the same lot number as the reported device were returned for analysis.The returned unused devices were tested; inspection performed confirmed no device malfunction.Based on a visual and functional inspection analysis of the returned devices, there is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE INTERMEDIATE 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: 5095385
• MDR Text Key: 26687751
• Report Number: 2024168-2015-05523
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060449
• 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
• Report Date: 10/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 22317HS-901
• Device Lot Number: 4110761
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/12/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2014
• 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