MAUDE Adverse Event Report: AV-TEMECULA-CT HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE

Catalog Number 1009664

Device Problems Detachment Of Device Component (1104); Difficult To Position (1467); Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).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 to treat a heavily tortuous unspecified coronary artery, and the right radial artery was accessed.There was difficulty advancing an unspecified guiding catheter; therefore, a 190 cm balance middleweight universal ii guide wire was advanced.However, the guide wire met resistance with the guiding catheter.This caused the guide wire tip to become prolapsed and form a knot when it passed through the guiding catheter.Therefore, another larger unspecified guiding catheter was used to go over the knotted tip of the guide wire.The tip of the guide wire was then being pulled out while the guiding catheter remained in place.However, the knotted tip of the guide wire separated in the radial artery after excessive force was applied; therefore, the physician applied manual pressure to keep the guide wire in place.The guiding catheter was then slowly advanced again while the remaining guide wire tip was being pulled back.It was then noted that the guide wire tip was attached to the guiding catheter.Therefore, the guide wire tip was simply withdrawn with the guiding catheter.The radial access was aborted and a femoral approach was done to successfully complete the procedure.There was a 10 minute delay in the procedure, but it was not clinically significant and there were no adverse patient effects.No additional information was provided.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was returned for analysis.The reported detachment, kinked, stretched and device operates differently than expected/prolapse were able to be confirmed.The reported difficult to position and difficult to remove were unable to be replicated in a testing environment due to the condition of the returned device.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 incidents from this lot.It should be noted the hi-torque guide wires for ptca, pta, and stents instructions for use states: if resistance is observed at any time, determine the cause under fluoroscopy and take remedial action as needed.Do not push, auger, withdraw, or torque a guide wire that meets resistance.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that due to the heavily tortuous anatomy and/or interaction with the guiding catheter the guide wire met resistance with the guiding catheter resulting in the guide wire tip to become prolapsed and form a knot when it passed through the guiding catheter; thus resulting in the reported difficulty to position.Attempts to pull out the tip of the guide wire resulted in the reported/noted device damages (kinked/bent tip, stretched coils) and ultimately resulted in the reported/noted coil/ribbon/tip detachment; thus resulting in the reported difficulty to remove.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

Subsequent to the initial report, additional information was received.The account provided device photos showing that the coils of the guide wire were stretched and several kinks were found at the tip.No additional information was provided.

• Brand Name: HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II 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): BARCELONETA, PUERTO RICO REG# 3005737652; 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: 7172683
• MDR Text Key: 96665950
• Report Number: 2024168-2018-00158
• Device Sequence Number: 1
• Product Code: DQX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072460
• 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
• Type of Report: Initial,Followup
• Report Date: 01/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 1009664
• Device Lot Number: 7110272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/24/2018
• 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): Required Intervention
• Patient Age: 57 YR
• Patient Weight: 136