MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE STEEL CORE 18 GUIDE WIRE WITH MICROGLIDE® COATING

Model Number	1003282
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/03/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device was received with the packaging unsealed over a length of 10 cm.The device was not used because it was no longer sterile.There was no patient involvement and no 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 report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device/pouch and reported opened package/sterility issue was confirmed.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Based on the reported information and returned analysis there is an indication of a potential lot specific product quality issue due to opened package/sterility issue.The investigation determined the reported unsealed pouch/sterility breach appears to be related to a potential quality issue.The issue is being addressed per internal operating procedures.Abbott vascular will continue to trend the performance of these devices.Na.

• Brand Name: HI-TORQUE STEEL CORE 18 GUIDE WIRE WITH MICROGLIDE® 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: 13374026
• Report Number: 2024168-2022-00940
• Device Sequence Number: 5136506
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: 08717648013959
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982876
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/04/2022

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: 06/30/2023
• Device Model Number: 1003282
• Device Catalogue Number: 1003282
• Device Lot Number: 1071661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/05/2022
• Supplement Date Received by Manufacturer: 02/11/2022
• Initial Report FDA Received Date: 01/27/2022
• Supplement Report FDA Received Date: 03/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/16/2021
• 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