MAUDE Adverse Event Report: ARGON MEDICAL DEVICES CLOSUREFAST GUIDEWIRE DOUBLE ENDED, PTFE, FIXED CORE 0.025" (0.64MM) X 150CM

Model Number	GW-025-150-DE1.5J
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
Physician used a guidewire during treatment of patients great saphenous vein (gsv).The lumen was flushed prior to use.The ifu (instruction for use) was followed during preparation, procedure, post-procedure.A guidewire was used for the insertion of the catheter.Tumescent infiltration was utilized.Local anesthesia was used.Transducer compression was used.It was reported the wire split when pulled out of catheter lumen and stuck the provider through the sterile glove.Procedure was completed as usual after wire was out.The vein is reported to have closed and no additional treatment was required.No patient injury reported.The device will not be returned as it was discarded by customer.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: CLOSUREFAST GUIDEWIRE DOUBLE ENDED, PTFE, FIXED CORE 0.025" (0.64MM) X 150CM
• Common Device Name: CLOSUREFAST GUIDEWIRE
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18436441
• Report Number: 0001625425-2024-00918
• Device Sequence Number: 7092551
• Product Code: DQX
• UDI-Device Identifier: 00886333227488
• UDI-Public: (01)00886333227488(17)280223(10)11464204
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: PRE-AMENDMEN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: GW-025-150-DE1.5J
• Device Lot Number: 11464204
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 09/01/2024
• Initial Report FDA Received Date: 01/03/2024
• Supplement Report FDA Received Date: 09/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2023
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown