MAUDE Adverse Event Report: ABBOTT VASCULAR HI-TORQUE FLOPPY II GUIDE WIRE WITH MICROGLIDE COATING

Model Number	22339MJ
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2022
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the hi torque floppy guide wire was noted to be rusty in the package.The package was sealed.There was no device use or patient involvement.Another hi torque floppy 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
It was reported that the hi torque floppy guide wire was noted to be rusty in the package.The package was sealed.There was no device use or patient involvement.Another hi torque floppy 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
The device was returned for analysis.The reported contamination problem (noted to be rusty) was unable to be confirmed; however there was noted embedded contamination throughout the coils and noted scratched teflon coating.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 reported contamination problem (noted to be rusty) was unable to be confirmed.The noted scratched teflon coating and the noted embedded contamination throughout the coils are likely the damages reported by the account; however a conclusive cause for the noted damages cannot be determined.The noted stretched tip coils and the noted bends throughout entire length of the guide wire possibly occurred due to handling or during packing for return analysis; however this cannot be confirmed.The investigation determined a conclusive cause for the reported/noted difficulties cannot be determined.There is no indication of a product quality issue with respect to manufacture, design or labeling.

• Brand Name: HI-TORQUE FLOPPY II 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: 15222648
• Report Number: 2024168-2022-08740
• Device Sequence Number: 12434370
• Product Code: DQX
• UDI-Device Identifier: 08717648080135
• UDI-Public: 08717648080135
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K913353
• 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): 10/06/2022

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: 09/30/2023
• Device Model Number: 22339MJ
• Device Catalogue Number: 22339MJ
• Device Lot Number: 1102061
• 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: 07/22/2022
• Supplement Date Received by Manufacturer: 09/26/2022
• Initial Report FDA Received Date: 08/13/2022
• Supplement Report FDA Received Date: 10/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2021
• 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