MAUDE Adverse Event Report: AV-TEMECULA-CT 014 HT WINN GUIDE WIRE

Catalog Number 1012467

Device Problems Detachment Of Device Component (1104); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524); Device Operates Differently Than Expected (2913)

Patient Problem Vessel Or Plaque, Device Embedded In (1204)

Event Date 02/07/2018

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 wires for ptca, pta, and stents 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.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 heavily calcified de novo, chronic total occlusion of the anterior tibial artery.A 300 cm winn guide wire was used; however, the tip of the guide wire prolapsed due to the anatomy when the guide wire was being torqued.Then the guide wire became stuck during advancement due to the anatomy, causing the tip to become separated.The tip was embedded in healthy tissue and there was a failed attempt to snare it.The patient was in stable condition and the blood flow in the leg was not affected by the embedded tip of the guide wire.Therefore, the separated guide wire tip was left in the anatomy, and the device was removed independently through an unspecified introducer sheath to complete the procedure.There was no adverse patient sequela reported.No additional information was provided.

• Brand Name: 014 HT WINN 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: 7284307
• MDR Text Key: 100509422
• Report Number: 2024168-2018-01258
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648156823
• UDI-Public: 08717648156823
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K091825
• 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
• Report Date: 02/20/2018

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: 04/30/2019
• Device Catalogue Number: 1012467
• Device Lot Number: 7051771
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2018
• Initial Date FDA Received: 02/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2017
• 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