MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM

Model Number 756508025

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Failure of Implant (1924); Unspecified Kidney or Urinary Problem (4503)

Event Date 03/03/2022

Event Type  malfunction  

Event Description

The urology department was implanted on november 16.On march 5, it was found that the patient's condition was not very good.When intervening to replace the drainage tube, it was found to be broken before the operation, and the patient had more urine crystals.

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 Description

The urology department was implanted on (b)(6).On (b)(6), it was found that the patient's condition was not very good.When intervening to replace the drainage tube, it was found to be broken before the operation, and the patient had more urine crystals.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no deviations or non-conformances were found.It was not necessary to check any other documentation in the course of investigating this complaint.A review of the product could not be performed, as no physical specimen was returned by the customer.However, photos provided by the customer do show an apparent and severe breakage.The photo shows a skater clotted in the distal end with biological matter.Shortly above where the pigtail begins, the catheter has been severed with enough force to expand and deform the plastic.There is no evidence of a manufacturing defect, and this error most likely occurred in the user environment.The complaint is not confirmed.As no sample was returned, and there is no evidence provided of a manufacturing defect, there is no corrective action to take at this time.

• Brand Name: SKATER ALL-PURPOSE DRAINAGE CATHETER LOCKING PIGTAIL 8FR X 25CM
• Type of Device: 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: 14139548
• MDR Text Key: 295899077
• Report Number: 0001625425-2022-00983
• Device Sequence Number: 1
• Product Code: GBQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 756508025
• Device Lot Number: 11316704
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other