MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE POWERTURN GUIDE WIRE WITH HYDROPHILIC COATING

Catalog Number 1044594

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/10/2023

Event Type  malfunction  

Event Description

It has been reported the procedure was in the subclavian vein with no stenosis or tortuosity.The hi-torque 014 bhw hydro 190cm guide wire and the ht powerturn 190cm guide wire could not be seen during procedure.The radiopacity tip mark of both guide wires could not be visualized.Another ht bhw guide wire was used in the procedure.There was no adverse patient effect and no clinically significant delay reported in the procedure.No additional information was provided.

Manufacturer Narrative

Manufacturer's investigation is still pending at this time.Results and conclusions will be provided in the final report.The hi-torque bhw guide wire referenced in b5 is filed under a separate medwatch report number.

Manufacturer Narrative

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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported poor visibility of tip marker.Factors that may contribute to poor visibility of tip marker include, but are not limited to, coil size, coil material properties, solder length, solder material, interaction accessory devices, imaging technique, or damage to the guide wire.In this case, a visual and functional inspection was performed on one unused/sterile unit returned from the same part and lot number.The inspection found no abnormalities or damage to the guide wire.This indicated a product quality issue did not contribute to the reported issue.Based on the information provided and because the device was not returned for analysis, it is unknown what may have caused the reported poor visibility of tip marker.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE POWERTURN GUIDE WIRE WITH HYDROPHILIC COATING
• Type of Device: 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: 17574714
• MDR Text Key: 321455542
• Report Number: 2024168-2023-08972
• Device Sequence Number: 1
• Product Code: DQX
• UDI-Device Identifier: 08717648173974
• UDI-Public: 08717648173974
• Combination Product (y/n): N
• Reporter Country Code: LO
• PMA/PMN Number: K112957
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 1044594
• Device Lot Number: 2092161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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
• Treatment: GE INTERNATIONAL MACHINE
• Patient Age: 78 YR
• Patient Sex: Female
• Patient Weight: 57 KG