MAUDE Adverse Event Report: ARGON MEDICAL DEVICES

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/14/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number was not provided, so the manufacturing and inspection records could not be reviewed.A review of three photos/images from the customer was performed, image forward to our vp of medical affairs according to image review " there really is not much that can be said about this.There does appear to be a foreign body located in the renal pelvis area noted on the nephrostogram which appears adjacent to a pre-existing catheter for which contrast was administered for performance of opacification of the renal collection system.The foreign body does appear to be similar in shape to the tip of the adjacent nephrostomy tube but being that it is only one view without oppositional obliques or lateral views it is hard to ascertain exactly where adjacent to the nephrostomy tube the foreign body lies.Without any other information with regards to adulteration of the skater catheter or without the product to evaluate it is impossible to make a determinant as to what may have been the causative mechanism for device fracture.There is no documentation of external influences that may have facilitated this incident nor to my recollection have there been a rash of other similar incidents with regards to tip separations from our catheters so it is not possible to make a causative statement or even a possible causative statement with regards to this per," and the complaint was not confirmed.According to the product experience report, sample not available to returned and the complaint was not confirmed, so no corrective action is required at this time.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.

Event Description

This event is unfortunately old, but i got aware at a visit (b)(6) 2023.The case is about a skater cath,where the tip of the cath has been cut off and remains loose in the patient.The patient is a very sick lady with cancer.Nephrostomy cath exchange (b)(6) 2019 because of disfunction of skater the exchange of the cath was very difficult because of the position of the pigtail.It seems like the tip of the skater cath was cut off during this procedure but physicians were not aware.(b)(6) 2020 a new exchange of skater cath where picture shows the loose tip in the patient.No clinical harm for the patient.Harm for the patient.The patient died in 2021 because of her cancer.The physician didn`t raised this as a complaint to me, but because he remembered the special case during our conversation.It seems like it has never been reported! it was not possible to get detailed information regarding the procedure, ref/lot number etc.We will attach pictures in mail.

• Brand Name: UNK
• Type of Device: UNK
• 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: 16443102
• MDR Text Key: 310375037
• Report Number: 0001625425-2023-00973
• Device Sequence Number: 1
• Product Code: LJE
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/27/2023

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/14/2023
• Initial Date FDA Received: 02/27/2023
• 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