MAUDE Adverse Event Report: ARGON MEDICAL DEVICES F8 SKATER BILIARY 40CM; SKATER DRAINAGE CATHETER

Model Number	755308040E
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/26/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The procedure was started with ultrasound-guided fine needle punctures.Amplatz guide wire is inserted.After dilation with a balloon catheter, ptc catheters are inserted.When the guide wire is to be removed from the right ptc drain, it is noted that the drain hose has come off (in what appears to be a manufacturing defect) at the height of the x-ray-tight marking.However, the strings to the string lock are still intact.Trying to remove the strings, and leave the remaining catheter in the intestine, but these are stuck and the catheter backs up nicely against the puncture hole.The catheter gets stuck,subcutaneously.I make a short incision in the skin and with mosquito debris down until the catheter is visualized after which it can be extracted.
Additional Manufacturer Narrative
A review of the batch records confirmed that the product was manufactured according to specification and no deviations, anomalies, or nonconformances were found.A review of the specification and drawings for lower level part number k758308040-ns confirmed that product was manufactured according to specification and drawing requirements.A review of returned product from the customer was performed, visual inspection of the product established that the catheter was separated right above the radiopaque band and the complaint was confirmed.As corrective action, operators had awareness training performed on ro bonding (mp-212 section 5.3).This was complete on 04/13/2021.The likely cause of the disconnection of the radiopaque (ro) band for part number 755308040e is improper bonding of the ro band.This may be caused by inconsistent adjustment by operators when using the ro band bonding pirf platform to bond the hub and pigtail sections of the catheter to the ro band.An adjustment to the ro band platform right clamp backstop controls the movement of the catheter into the generator.If an improper adjustment is made, the catheter may be inserted either too far or not far enough into the generator, which may result in an improper bond.This is a follow-up report for medwatch 1625425-2021-00915.Our system was changed and the final follow-up could not be submitted until data was transferred to the new system.

• Brand Name: F8 SKATER BILIARY 40CM
• Common Device Name: SKATER DRAINAGE CATHETER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15168498
• Report Number: 0001625425-2022-01053
• Device Sequence Number: 15035124
• Product Code: FGE
• UDI-Device Identifier: 00886333006113
• UDI-Public: 00886333006113
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K073672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/04/2022

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
• Device Expiration Date: 05/18/2025
• Device Model Number: 755308040E
• Device Catalogue Number: 755308040
• Device Lot Number: 11310394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2021
• Initial Report FDA Received Date: 08/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown