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

Model Number	1003282
Medical Device Problem Codes	Break (1069); Stretched (1601)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/01/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during use of the steelcore guide wire, there was a break in the coils and the springs appear to have opened [stretched coils].There were no reported adverse patient effects and there was extended time in the procedure but no effect was reported to the patient.No additional information was provided.
Additional Manufacturer Narrative
The customer reported the device is not returning.Investigation is not yet complete.A follow up report will be submitted with all additional relevant information.
Additional Manufacturer Narrative
The product was not returned to abbott vascular 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.Based on the review of similar incident(s) there is no indication of a lot specific product quality issue.A cine photo was received and reviewed by an abbott vascular clinical specialist.The cine review concluded that the distal radiopaque portion of the guide wire has coils that are stretched giving the appearance that a portion of the distal wire is not radiopaque.The investigation determined the reported stretched coils appear to be related to case circumstances of the procedure.In this case, based on the reported information and cine review, it is likely that during the procedure the coils became stretched against the anatomy and/or other devices causing the stretched coils not to be visible under angiography.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.H6 medical device problem code 1069 was removed.
Event or Problem Description
It was reported that during use of the steelcore guide wire, there was a break in the coils and the springs appear to have opened [stretched coils].There were no reported adverse patient effects and there was extended time in the procedure but no effect was reported to the patient.Subsequent to the initially filed report, the following information was provided: the core of the wire was intact but the coil seemed pulled in a section and wasn't visible on angiography.The coils were only stretched.No additional information was provided.

• 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: 12816797
• Report Number: 2024168-2021-10381
• Device Sequence Number: 11956521
• Product Code: DQX
• UDI-Device Identifier: 08717648013959
• UDI-Public: 08717648013959
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2022

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: 04/30/2023
• Device Model Number: 1003282
• Device Catalogue Number: 1003282
• Device Lot Number: 1051061
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2021
• Supplement Date Received by Manufacturer: 01/11/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 01/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2021
• 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 Age: 79 YR
• Patient Sex: Male
• Patient Weight: 61 KG