MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE SUPRACORE GUIDE WIRE

Model Number	1002703-02
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/09/2022
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.Na.
Event or Problem Description
It was reported that the supracore guide wire was opened under sterile conditions and inspected.The coils of the wire were separated but the core was intact.The device was not used and there was no patient involvement.A new supracore guide wire was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned device.The reported tip break was not confirmed; however, the stretched coils noted during return analysis may be the damage the account was referring to.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/complaints from this lot.The investigation was unable to determine a conclusive cause for the reported tip break.The reported tip break was unable to be confirmed by return analysis; however, the stretched coils noted during return analysis may be the damage the account was referring to.Factors that may contribute to a tip break / stretched coils prior to use include, but are not limited to, inadvertent mishandling during unpackaging, damage incurred during manufacturing, and/or damage incurred during shipping.In this case, the stretched coils distal to the center solder are consistent with damage incurred during unpackaging; however, this cannot be confirmed.Additionally, a manufacturing investigation was performed and found no indication of a product quality issue.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: HI-TORQUE SUPRACORE 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 # 2024168; 26531 ynez road; temecula CA 92591 4628
• Manufacturer Contact: lindsey bell ; 26531 ynez rd.; temecula, CA 92591-4628 ; 9519143996
• MDR Report Key: 15887627
• Report Number: 2024168-2022-12036
• Device Sequence Number: 14728288
• Product Code: DQX
• UDI-Device Identifier: 08717648033001
• UDI-Public: 08717648033001
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K980119
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2023

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: 05/31/2024
• Device Model Number: 1002703-02
• Device Catalogue Number: 1002703-02
• Device Lot Number: 2060961
• 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: 11/10/2022
• Supplement Date Received by Manufacturer: 01/30/2023
• Initial Report FDA Received Date: 11/30/2022
• Supplement Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2022
• 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