MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE TURNTRAC GUIDE WIRES

Catalog Number	1020013
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a 100% stenosed de novo lesion in the mid right coronary (mrca) with heavy calcification and mild tortuosity.The 014 ht turntrac 190 guide wire was attempted to cross the target lesion with a non-abbott balloon catheter; however, the guide wire became caught with the stenosed lesion.The guide wire was pulled while pushing the balloon and the micro catheter at that time.Angiography then showed that the coils of the guide wire were stretched; therefore, shockwave therapy was performed to remove the guide wire from the patient.Another same size turntrac guide wire was used to complete the procedure.It was noted that both turntrac guide wires were used passed the expiration date.There was no adverse patient sequela.No additional information was provided.
Additional Manufacturer Narrative
The device was not returned for analysis.Electronic lot history record (elhr) and corrective and preventive actions (capa) reviews were performed and revealed no indication of a product quality issue.A review of the complaint handling database was not performed as there were no reported device issues.Reportedly, the turntrac guidewire was used in the procedure past the expiration date.It should be noted that the hi-torque turntrac guide wire instructions for use (ifu) label symbol legend states: use by: (date indicated on the chipboard box/pouch label).The expiration date on the specific product labels could not be confirmed.However, a review of the labels attached to the electronic lot history record for this lot was conducted and all labels indicated an expiration date (use by date) of 2/29/2024.However, the device was used on (b)(6)2024.There were no adverse patient effects and there was no clinically significant delay in the procedure.The expiration date of the product is important for sterility, efficacy, and performance of the device.The investigation determined the reported difficulties appear to be related to deviation of the instructions for use as it is likely that the device was inadvertently used after the use by date.Based on the reported information and results of the complaint investigation there is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6: medical device problem code 2017 clarifier - use after expiration the additional ht turntrac device referenced in b5 is filed under separate medwatch report number.

• Brand Name: HI-TORQUE TURNTRAC GUIDE WIRES
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 19305742
• Report Number: 2024168-2024-05810
• Device Sequence Number: 20660494
• Product Code: DQX
• UDI-Device Identifier: 08717648222702
• UDI-Public: (01)08717648222702(17)240229(10)2031061
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K173795
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 1020013
• Device Lot Number: 2031061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/22/2024
• Initial Report FDA Received Date: 05/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/10/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARAVEL MICRO CATHETER; CORSAIR BALLOON DILATATION CATHETER
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 100 KG