MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE BALANCE® GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING

Model Number	28000-HC
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received.Analysis is not yet complete.A follow-up report will be submitted with all additional relevant information.
Event or Problem Description
It was reported that prior to use of the hi torque balance guide wire, the tip was kinked when being removed from the packaging.It appeared the braiding [coils] of the wire at the tip had been removed but were still attached to the core.It could not be determined if the core was intact.Reportedly this was noted before use and the device was not used and there was no patient involvement.A new bmw guide wire was used to complete the procedure.There was no clinically significant delay in the procedure.No additional information was provided.
Event or Problem Description
Subsequent to the initially filed report, the following information was provided: the device had blood on it due to being in the sterile field and being handled but it was not used in the patient.
Additional Manufacturer Narrative
The device was returned for analysis.The reported break and kink were unable to be confirmed; however, there were noted damages (bent shaping ribbon, misaligned/stretched coils).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 from this lot.The investigation determined the reported difficulties appear to be related to circumstances of the procedure as it is likely that during removal from the dispenser coil inadvertent mishandling resulted in the reported kink and break/noted bent shaping ribbon, misaligned/stretched coils.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE BALANCE® GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING
• 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: 14477112
• Report Number: 2024168-2022-05519
• Device Sequence Number: 5336537
• Product Code: DQX
• UDI-Device Identifier: 08717648080500
• UDI-Public: 08717648080500
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K973494
• 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): 07/08/2022

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: 07/31/2023
• Device Model Number: 28000-HC
• Device Catalogue Number: 28000-HC
• Device Lot Number: 1082771
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/29/2022
• Supplement Date Received by Manufacturer: 06/16/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/27/2021
• 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