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

Model Number	1044592
Medical Device Problem Codes	Difficult to Remove (1528); Stretched (1601); Device Damaged by Another Device (2915)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the procedure was to treat a lesion located in the left anterior descending coronary artery (lad).Two powerturn guide wires were advanced to their intended location, one wire down the diagonal branch.The 3.5x15mm xience skypoint stent was implanted, without issue, in the lad lesion.During removal of the guidewire from the diagonal branch, resistance was noted, the guidewire became stretched and, the skypoint stent was explanted.A new guide wire was positioned and a 3.5x18mm xience skypoint was advanced and implanted in the lesion without issue.There was no adverse patient sequela and no clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual and dimensional inspection was performed on the returned device.The reported device damaged by another device/caused damage and difficult to remove could not be tested as it was based on operational context.The reported stretched (coils) was confirmed.A review of the electronic lot history record (elhr), corrective action tracking system for the web (catsweb) database review and similar incident query for this product was not performed because the lot number was not reported.The investigation determined the reported difficulties appear to be related to the operational context of the procedure.In this case, it is likely that the guide wire interacted with the implanted stent during removal, as resistance was noted, resulting in the reported difficult to remove.Manipulation of the guide wire, when resistance with the stent was met, likely resulted in the reported stretched coils, stent explantation, and bent core.There is no indication of a product quality issue with respect to manufacture, design, or labeling.The 3.5x15mm xience skypoint stent mentioned was filed under a different mfr number: 2024168-2023-01797.

• Brand Name: HI-TORQUE POWERTURN FLEX GUIDE WIRE WITH HYDROPHILIC COATING
• 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: 16519235
• Report Number: 2024168-2023-02516
• Device Sequence Number: 19671415
• Product Code: DQX
• UDI-Device Identifier: 08717648173936
• UDI-Public: 08717648173936
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K112957
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/09/2023

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 Model Number: 1044592
• Device Catalogue Number: 1044592
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/20/2023
• Initial Report FDA Received Date: 03/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Patient Age: 65 YR
• Patient Sex: Male