MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER CENTESIS CATHETER 4FR X 15CM

Model Number	700304015
Health Effect - Clinical Codes	Pain (1994); Obstruction/Occlusion (2422)
Date of Event	07/30/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
According to the product experience 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 allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.
Event or Problem Description
On (b)(6) 2022, the patient was admitted to the hospital for 3 days due to the stone in the middle and lower segment of the left ureter with left hydronephrosis.The doctor performed the kidney drainage tube placement under the guidance of b-ultrasound.The doctor used the drainage tube and accessories for puncture and drainage.During the operation, it was found that the drainage tube and the needle core could not be separated, and no effusion was drained after the tube placement.It will affect the operation effect and increase the patient's pain.

• Brand Name: SKATER CENTESIS CATHETER 4FR X 15CM
• 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: 15249758
• Report Number: 0001625425-2022-01067
• Device Sequence Number: 17604170
• Product Code: GBQ
• UDI-Device Identifier: 00886333005789
• UDI-Public: 00886333005789
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 08/18/2022

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
• Operator of Device: Health Professional
• Device Model Number: 700304015
• Device Catalogue Number: 700304015
• Device Lot Number: 11405496
• 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: 08/09/2022
• Initial Report FDA Received Date: 08/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Other
• Patient Sex: Unknown