MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER SINGLE-STEP DRAINAGE CATHETER SET WITH LOCKING PIGTAIL

Catalog Number 756506025E

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

Patient Problems Fistula (1862); Rupture (2208)

Event Date 10/20/2020

Event Type  malfunction  

Manufacturer Narrative

The sample is indicated as unavailable for evaluation.Without the physical evidence to review, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

The patient was admitted to hospital due to urination pain and dysuria.At 11:00 on (b)(6) 2020, bilateral renal puncture and fistula was performed under b-ultrasound localization.The operation was smooth, the catheter was properly fixed, and the patient had no discomfort.The doctor told the patient to keep the catheter clear, do not fold and warp.At 12:40 on (b)(6) the external fistula of the right kidney was ruptured when the patient turned over.Later, the broken fistula was taken out in the next operation.The hospital has reported the case as an ae on (b)(6).

• Brand Name: SKATER SINGLE-STEP DRAINAGE CATHETER SET WITH LOCKING PIGTAIL
• Type of Device: SKATER
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 11113535
• MDR Text Key: 226027099
• Report Number: 1625425-2020-00809
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 01/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2024
• Device Catalogue Number: 756506025E
• Device Lot Number: 11254389
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/04/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/09/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other