MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL WITH RADIOPAQUE BAND 10F X 40CM

Model Number	755310040
Medical Device Problem Codes	Fluid/Blood Leak (1250); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Event or Problem Description
On (b)(6), 2022, a drainage tube disconnection incident occurred at (b)(6) hospital in the area.According to clinical description, the drainage tube was not operated during its release, and was placed inside the stent without being cut by the stent.After the catheter was placed, strict suture treatment was performed.The patient went to the hospital for a week after the catheter was placed, and before the catheter was removed, imaging revealed that the contrast agent had leaked out of the body, resulting in the disconnection of the tube.It was found that the catheter was broken in the body, after removing the first half, observation was also conducted, and it was clinically determined that the drainage tube is a split type.
Additional Manufacturer Narrative
A review of the manufacturing and inspection records for this lot was conducted, and no deviations and non-conformances were recorded.A review of the returned product from the customer was performed; visual inspection of the drainage skater returned from the customer found the drainage tube separated or broke from the radiopaque marker band, and the complaint was confirmed.The possible root cause of this issue could be drainage skater tube separated from the radiopaque marker band.
Event or Problem Description
On august 3, 2022, a drainage tube disconnection incident occurred at laixi city people's hospital in the area.According to clinical description, the drainage tube was not operated during its release, and was placed inside the stent without being cut by the stent.After the catheter was placed, strict suture treatment was performed.The patient went to the hospital for a week after the catheter was placed, and before the catheter was removed, imaging revealed that the contrast agent had leaked out of the body, resulting in the disconnection of the tube.It was found that the catheter was broken in the body, after removing the first half, observation was also conducted, and it was clinically determined that the drainage tube is a split type.

• Brand Name: SKATER BILIARY DRAINAGE CATHETER LOCKING PIGTAIL WITH RADIOPAQUE BAND 10F X 40CM
• Common Device Name: SKATER
• 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: 17595821
• Report Number: 0001625425-2023-01165
• Device Sequence Number: 7420804
• Product Code: FGE
• UDI-Device Identifier: 00886333006137
• UDI-Public: 00886333006137
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/22/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: 755310040
• Device Lot Number: 11316267
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 08/10/2023
• Supplement Date Received by Manufacturer: 08/10/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/22/2023
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown