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); Entrapment of Device (1212); Improper or Incorrect Procedure or Method (2017); Device Operates Differently Than Expected (2913)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/02/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device 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 incidents from this lot.It should be noted the hi torque guide wire instructions for use, states: do not allow the guide wire tip to remain in a prolapsed condition.Failure to do so may result in vessel trauma, guide wire damage, guide wire tip separation, or stent damage.The investigation determined the reported difficulties appear to be related to use error and circumstances of the procedure.As the stent was deployed it resulted in the prolapsed guide wire being jailed in the diagonal.Manipulation to remove the guide wire resulted in the reported tip detachment.There is no indication of a product quality issue with respect to manufacture, design or labeling.

Event Description

It was reported that the procedure was to treat a moderately tortuous, mildly calcified de novo lesion in the mid left anterior descending coronary artery that was 90% stenosed.The procedure on (b)(6) 2017 was to treat a bifurcated lesion in the lad/diagonal vessel with a 3.0 x 22mm non-abbott stent.During the operation, two balance middle weight (bmw) universal ii guide wires were used in the lad and first diagonal (dx).The bmw ii in the dx was prolapsed at the tip which was not an issue at the time.A stent was deployed in the lad which jailed the bmw ii in the diagonal.When this wire was attempted to be removed the wire tip did not straighten as intended but formed a tight ball in the stent struts.With considerable force, the wire was removed but it was noticed that the wire tip remained in the stent struts and that the wire coils had uncoiled and extended into an arteriotomy and subclavian vessels.The case was completed with a jailed wire in the vessel and the patient remained in the hospital until the next procedure.The patient was brought back for surgery on (b)(6) 2017 (a week later) to try and remove the wire tip and coils.The loose coils were able to be snared and most were removed- if not all - of the remaining wire tip.There may be wire tip still located in the deployed stent but angiograms are inconclusive as it may just be stent deformation as a result of pulling the wire in the initial procedure.There have been no adverse patient effects reported since the (b)(6) 2017 procedure.It remains unclear which guide wire was used for which vessel.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: 7018768
• MDR Text Key: 91772981
• Report Number: 2024168-2017-08869
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648118715
• UDI-Public: 08717648118715
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K072460
• 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
• Report Date: 11/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 1009664
• Device Lot Number: 7012372
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2017
• Initial Date FDA Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Weight: 94