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

Model Number	1044594J
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that an ht powerturn flex guide wire (gw) delaminated at the marker height.There was no report of an adverse patient effect or a clinically significant delay in procedure.No additional information was provided.
Additional Manufacturer Narrative
The device is expected to be returned for evaluation.It has not yet been received.A follow-up will be submitted with all relevant information.
Additional Manufacturer Narrative
The device was returned for analysis.The reported peeled / delaminated was unable to be confirmed.Additionally, the coils were noted to be stretched with a core separation noted.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 from this lot.The reported peeled / delaminated was unable to be confirmed.Additionally, as there was no reported damage noted to the device during the inspection prior to use, the investigation determined the noted stretched coils and the noted material separation appear to be due to inadvertent mishandling during use, post procedure or during packing for return analysis.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
• 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: 14251855
• Report Number: 2024168-2022-04658
• Device Sequence Number: 19932838
• Product Code: DQX
• UDI-Device Identifier: 08717648173981
• UDI-Public: 08717648173981
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2022

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: 10/31/2023
• Device Model Number: 1044594J
• Device Catalogue Number: 1044594J
• Device Lot Number: 1112361
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/11/2022
• Supplement Date Received by Manufacturer: 07/14/2022
• Initial Report FDA Received Date: 04/29/2022
• Supplement Report FDA Received Date: 07/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2021
• 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 Sex: Unknown