MAUDE Adverse Event Report: AV-TEMECULA-CT ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Catalog Number 1003309H

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 08/29/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).Evaluation summary: visual, dimensional and functional inspections were performed on the returned device.The reported separation, failure to advance and device operating differently than expected was confirmed.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot was performed and revealed no other incidents.It should be noted that the hi torque guide wire instructions for use states: do not: push, auger, withdraw or torque a guide wire that meets resistance.Additionally, the ifu states: do not: allow the guide wire tip to remain in a prolapsed condition.The investigation determined the reported difficulties to be related to the patient anatomical conditions and the patient effect appears to be related to operational circumstances of the procedure.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.

Event Description

It was reported that the procedure was to treat a chronic total occlusion in the heavily calcified proximal left anterior descending (lad) coronary artery.The ht cross-it 100 xt guide wire was advanced to the lesion, but met resistance and would not cross.The physician tried torqueing the wire, but the tip got stuck in the plaque and formed a loop.When the guide wire was removed from the anatomy, the loop that had formed broke off.It was determined that the separated tip was in the subintimal of the lad; therefore, no attempt was made to remove the tip from the anatomy.An ht cross-it 200 xt guide wire was then selected for the procedure, but it met resistance and would not cross.The guide wire was removed from the anatomy and the procedure was stopped at that point.The patient did not complain of any chest pain or discomfort following the procedure.No additional information was provided.

• Brand Name: ACS HI-TORQUE CROSS-IT GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• 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: 6884262
• MDR Text Key: 86980041
• Report Number: 2024168-2017-07666
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648034800
• UDI-Public: 08717648034800
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K060449
• 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: 09/21/2017

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: 08/31/2018
• Device Catalogue Number: 1003309H
• Device Lot Number: 6092361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2017
• Initial Date FDA Received: 09/21/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2016
• 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): Other