MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER INTRODUCER SYSTEM

Model Number	651506300
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted.No deviations or non-conformances were found.There were no other complaints reported in the lot.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.Determining a root cause and corrective action is not possible.No corrective action is required at this point.If the samples are returned at a later date, then this complaint may be reopened for re-evaluation.
Event or Problem Description
The reporter indicated the introducer with the thick tip was not able to pierce the renal and hepatic capsules easily.During the nephrostomy procedure, the introducer had difficulty perforating the kidney and caused renal bleeding.
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.No deviations or non-conformances were found.The customer did not return any samples for evaluation.Additionally, no photographic or visual evidence was submitted that would have allowed this allegation to be reviewed.Without the necessary evidence, a thorough investigation cannot be performed.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: SKATER INTRODUCER SYSTEM
• Common Device Name: SKATER
• 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: 19442137
• Report Number: 0001625425-2024-01035
• Device Sequence Number: 12842404
• Product Code: GCB
• UDI-Device Identifier: 00886333004515
• UDI-Public: (01)00886333004515(17)280928(10)11500789
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/31/2024

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: 651506300
• Device Lot Number: 11500789
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2024
• Supplement Date Received by Manufacturer: 05/23/2024; 08/31/2024
• Initial Report FDA Received Date: 06/01/2024
• Supplement Report FDA Received Date: 06/22/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/06/2023
• 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