MAUDE Adverse Event Report: ABBOTT VASCULAR ACS HI-TORQUE ALLSTAR¿ GUIDE WIRE

Model Number	1001741J
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
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 allstar guide wire shaft was wiped with a sterile gauze before advancing in the anatomy and wire fragments were noted on the gauze.The coils separated from the wire.Another unspecified guide wire was used to successfully complete the procedure.There was no patient involvement and no clinically significant delay in the procedure.No additional information was provided.
Additional Manufacturer Narrative
A visual inspection was performed on the returned guide wire and the reported core separation was unable to 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 identified no other similar incidents and/or complaints reported from this lot.Possible factors that may contribute to guide wire breaks/separations can be affected by numerous factors including, but not limited to, manufacturing, guide wire damage, guide wire re-insertions, handing/manipulation, tensile or torsional loads beyond its design limits, entanglement with other devices or anatomical conditions.The investigation was unable to determine a conclusive cause for the reported separation.Based on the reported information, it is possible that inadvertent mishandling and/or manipulation during preparation of the guide wire caused the noted scratches and scrapings of teflon.Additionally, the stretched coils likely occurred when wiping the guide wire with the gauze causing the appearance of the coil break; however, this could not be confirmed.There is no indication of a product quality issue with respect to manufacture, design, or labeling.

• Brand Name: ACS HI-TORQUE ALLSTAR¿ 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: 12933738
• Report Number: 2024168-2021-11063
• Device Sequence Number: 20060124
• Product Code: DQX
• UDI-Device Identifier: 08717648025952
• UDI-Public: 08717648025952
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K972142
• 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): 02/03/2022

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: 02/28/2023
• Device Model Number: 1001741J
• Device Catalogue Number: 1001741J
• Device Lot Number: 1032461
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 12/06/2021
• Supplement Report FDA Received Date: 02/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/24/2021
• 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