MAUDE Adverse Event Report: ARGON MEDICAL DEVICES JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 5F X 105CM STRAIGHT

Model Number	190095
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The sample is not available for return.The investigation is currently in progress.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
The reporter indicated the device will not open or close.Additional information was requested and received indicating the patient needed surgical exploration of the groin to retrieve the broken device inside the femoral vein, followed by surgical repair of the femoral vein.The intended procedure was abandoned.
Additional Manufacturer Narrative
Additional information provided in h.6.And h.11.A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.According to the customer 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 complaint to be reviewed.Without the necessary evidence, a thorough investigation cannot be completed.Determining a root cause and corrective action is not possible.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.
Additional Manufacturer Narrative
Udi related data quality updates only.

• Brand Name: JAWZ ENDOMYOCARDIAL BIOPSY FORCEPS 5F X 105CM STRAIGHT
• Common Device Name: JAWZ
• 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: 19221234
• Report Number: 0001625425-2024-01005
• Device Sequence Number: 15193823
• Product Code: DWZ
• UDI-Device Identifier: 00886333206865
• UDI-Public: (01)00886333206865(17)290119(10)5645695
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K951447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2024

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: 190095
• Device Lot Number: 5645695
• Was Device Available for Evaluation?: No
• 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: 04/01/2024
• Supplement Date Received by Manufacturer: 05/28/2024; 08/24/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 06/26/2024; 08/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2024
• 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: Required Intervention
• Patient Sex: Unknown