MAUDE Adverse Event Report: ABBOTT VASCULAR HT VERSATURN GUIDE WIRE

Model Number	1013319
Medical Device Problem Codes	Break (1069); Stretched (1601); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to be returned for investigation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that the 014 ht versaturn guide wire was removed from packaging and the tip was noted to be fractured.Loose spirals in that area could be observed.Another unspecified guide wire was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay reported.No additional information was provided.
Additional Manufacturer Narrative
A visual and chemical analysis was performed on the returned device.The reported stretched coils and contamination were confirmed.The reported break could not be confirmed.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 of the reported lot did not indicate a lot specific quality issue.The investigation was unable to determine a conclusive cause for the reported difficulties.Factors that may contribute to stretched coils upon unpackaging include, but are not limited to, damage incurred during manufacturing, damage incurred during shipping, or inadvertent mishandling during unpackaging.Factors that may contribute to contamination include, but are not limited to, contamination incurred during manufacturing, contamination incurred during shipping, or inadvertent contamination during unpackaging.In this case, a chemical analysis was performed on the returned device to investigate the reported corrosion on the guide wire.Chemical analysis confirmed that no corrosion was present on the guide wire.A conclusive source of the reported contamination cannot be determined due to handling of the guide wire after unpackaging, exposure to elements during transit back to abbott, and due to the decontamination process the device underwent upon return.Additionally, a visual and dimensional inspection was performed on unused/sterile units from the same part and lot number.The inspection found no abnormalities, contamination, or coil damage.Furthermore, a cause for the reported stretched coils in unable to be determined.There is no indication of a product quality issue with respect to manufacture, design, or labeling.
Event or Problem Description
Subsequently, after the initial was filed returned device analysis found that the guide wire was corroded.Follow up with the account reported that the corrosion was observed.No additional information was provided.

• Brand Name: HT VERSATURN GUIDE WIRE
• Common Device Name: GUIDE WIRE
• Manufacturer (Section D): ABBOTT VASCULAR; 26531 ynez rd.; temecula CA 92591 4628
• Manufacturer (Section G): ABBOTT VASCULAR, REG # 3005737652; road no.2 km 58.0 cruce dávila; barceloneta PR 00617
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 16455673
• Report Number: 2024168-2023-02051
• Device Sequence Number: 15065809
• Product Code: DQX
• UDI-Device Identifier: 08717648198458
• UDI-Public: 08717648198458
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K141782
• 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): 06/30/2023

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 Expiration Date: 01/31/2024
• Device Model Number: 1013319
• Device Catalogue Number: 1013319
• Device Lot Number: 2022671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 06/09/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/26/2022
• 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
• Patient Sex: Unknown