MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER NEPHROSTOMY KIT LOCKING 8F X 35CM

Model Number 757308600

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/17/2023

Event Type  malfunction  

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 Description

The patient underwent pyelostomy (percutaneous pyeloplasty and drainage) due to ureteral stones and hydronephrosis, uremia, and b-ultrasound.The entire process was smooth, and the patient did not report any significant discomfort.The process of ureteroscopic lithotripsy was smooth, and there was significant bleeding after removing the fistula tube.Dsa and bladder blood clot flushing were performed on (b)(6).

Event Description

(b)(6).The patient underwent pyelostomy (percutaneous pyeloplasty and drainage) due to ureteral stones and hydronephrosis, uremia, and b-ultrasound.The entire process was smooth, and the patient did not report any significant discomfort.The process of ureteroscopic lithotripsy was smooth, and there was significant bleeding after removing the fistula tube.Dsa and bladder blood clot flushing were performed on (b)(6).

Manufacturer Narrative

This was identified as a duplicate to (b)(4).

• Brand Name: SKATER NEPHROSTOMY KIT LOCKING 8F X 35CM
• 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: 17079296
• MDR Text Key: 316704438
• Report Number: 0001625425-2023-01093
• Device Sequence Number: 1
• Product Code: GBQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 757308600
• Device Lot Number: 11439033
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other