MAUDE Adverse Event Report: ABBOTT VASCULAR HT TURNTRAC; GUIDE WIRE

Catalog Number	1020010
Medical Device Problem Codes	Break (1069); Difficult to Remove (1528); Stretched (1601); Improper or Incorrect Procedure or Method (2017); Failure to Advance (2524)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: device code 2017: against resistance.G9: exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.The device was received.Investigation is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the procedure was performed to treat a lesion in the moderately tortuous, moderately calcified, 90% stenosed proximal left anterior descending coronary artery.A turntrac flex guide wire failed to cross due to the anatomy.Then, the guide wire became stuck and difficult to remove due to the anatomy.The guide wire was pulled a bit and the coils became stretched, but the coils and core were intact.A non-abbott micro catheter was advanced so the guide wire could be removed.An unspecified guide wire was used to successfully complete the procedure.There were no adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
Visual and dimensional inspections were performed.The reported guide wire stretched coils and guide wire breakage/separation was confirmed.The reported failure to advance and remove were unable to be replicated in a testing environment as they were based on operational circumstances.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.There was no damage noted to the guide wire during the inspection prior to use which suggests a product quality issue did not contribute to the reported difficulties.The investigation determined the reported difficulties appear to be related to circumstances of the procedure.It should be noted that the guide wire hi-torque turntrac instructions for use (ifu) 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.Do not torque a guide wire if the tip becomes entrapped within the vasculature.Although it was reported that the physician pulled the wire in the attempts to remove the device, this was due to the guide wire being trapped with the anatomy, therefore the pulling the guide wire during removal of the guide wire seemed to be a reasonable clinical response to the difficulties.Manipulation of the guide wire against resistance likely resulted in the reported/noted break/separation, stretched coils and subsequent noted damages.There is no indication of a product quality issue with respect to manufacture, design or labeling.Exemption number e2019001-permits numbering sequence to begin with 10000, to avoid duplication of report numbers due to process transition.There may be gaps in numbering for reports submitted during the transition period.
Event or Problem Description
Subsequent to the initially filed report, the following information was received: the turntrac flex guide wire core was separated during removal, but the coils were intact.No additional information was provided.

• Brand Name: HT TURNTRAC
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• MDR Report Key: 8898443
• Report Number: 2024168-2019-10893
• Device Sequence Number: 16548611
• Product Code: DQX
• UDI-Device Identifier: 08717648222641
• UDI-Public: 08717648222641
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/04/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2020
• Device Catalogue Number: 1020010
• Device Lot Number: 8060561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2019
• Initial Date Received by Manufacturer: 07/23/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 11/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARAVEL MICROCATHETER; CARAVEL MICROCATHETER
• Outcome Attributed to Adverse Event: Required Intervention