MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 10FR X 25CM; SKATER CATHETER

Model Number	756610025
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sample is not available for return.An image was provided for investigation.A follow-up report will be submitted upon investigation completion.
Event or Problem Description
Male patient admitted via emergency room with nephrostomy tube issue (prev placed device).Catheter broke right at skin where sutured, upon removing, the catheter broke recoiling into kidney.Second skater placed alongside initial catheter as patient awaits urology consult for further intervention.Images were provided.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded.A review of photos and video from the customer was performed, and drainage skater tube breakage, distal end separation, and complaint was confirmed.The exact root cause is unable to be determined because the faulty device did not return to the manufacturer for the investigation.The complaint was confirmed based on the image and video provided by the customer.Without the device, it was very hard to evaluate breakage related to the manufacture or device mishandling during the procedure.No corrective action is required at this time because the root cause is not confirmed with confidence, such as device breakage due to the manufacture or mishandling by the user.There have been no similar complaints for the lot number.
Additional Manufacturer Narrative
Udi related data quality updates only.Corrected information provided in d.4.

• Brand Name: SKATER ALL-PURPOSE AND NEPHROSTOMY DRAINAGE SET LOCKING 10FR X 25CM
• Common Device Name: SKATER CATHETER
• 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: 18557681
• Report Number: 0001625425-2024-00924
• Device Sequence Number: 17759695
• Product Code: GBO
• UDI-Device Identifier: 00886333217816
• UDI-Public: (01)00886333217816(17)280803(10)11491848
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• 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: 756610025
• Device Lot Number: 11491848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2024
• Supplement Date Received by Manufacturer: 03/11/2024; 08/31/2024
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 04/05/2024; 08/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2023
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown