MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SKATER NEPHROSTOMY CATHETER-LOCKING PIGTAIL

Catalog Number 755608035

Device Problems Complete Blockage (1094); Flushing Problem (1252)

Patient Problems Foreign Body In Patient (2687); No Code Available (3191)

Event Date 09/26/2018

Event Type  malfunction  

Manufacturer Narrative

Argon found the complaint on maude database.The complainant's information is not available so argon cannot request for the return of the device.Without such evidence, the complaint cannot be confirmed.If additional information is received in the future, a follow-up report will be provided.

Event Description

Pt is a (b)(6) female, (b)(6) pregnant, with history of left pcn (percutaneous nephrolithotomy) for obstructive stone placed on (b)(6) 2018.Patient presented with decreased urine output from the drain, and the tube could not be flushed.Patient sent to hospital for interventional radiology procedure to remove catheter.Unable to pass wire into the nephrostomy as it was occluded.Unable to remove the catheter, then end (1-2 cm) of the catheter broke into soft tissues.Attempted to remove with help of a surgeon, however, the piece could not be removed at this time.The patient was admitted to surgical service and sent to the operating room today, (b)(6) 2018, for removal.

• Brand Name: SKATER NEPHROSTOMY CATHETER-LOCKING PIGTAIL
• 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: 10591827
• MDR Text Key: 209348560
• Report Number: 1625425-2020-00531
• Device Sequence Number: 1
• Product Code: GBO
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 09/25/2020

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: 05/23/2023
• Device Catalogue Number: 755608035
• Device Lot Number: 11218759
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/28/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/23/2018
• 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): Required Intervention