MAUDE Adverse Event Report: URESIL, LLC TRU-SET NEPHROSTOMY CATHETER

Model Number	NCL2-0835HB
Medical Device Problem Codes	Detachment Of Device Component (1104); Expulsion (2933)
Health Effect - Clinical Code	Cellulitis (1768)
Date of Event	03/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have reviewed the manufacturing records for ncl2-0835h lot 5g631 and did not find any related issues.Uresil has biocompatibility testing on file for all parts of the catheter, including the stress relief, and it is biocompatible.Uresil has not received any other reports of similar issues with its catheters for this or any other lot since the implementation of adhesive-lined stress reliefs in mid-2012; uresil has sold hundreds of thousands of catheters containing the adhesive-lined stress relief in that time.Each lot of adhesive-lined stress reliefs is verified for presence of adhesive and subjected to a dimensional inspection.During catheter assembly, the tubing is attached with adhesive to the hub and then the adhesive-lined stress relief is shrunk to the size of the hub before being subjected to a 100% leak test.The stress relief has an adhesive lining that would make it difficult to move off the hub, and further it is shrunk to the diameter of the catheter during manufacturing.The stress relief is not part of the working length of the catheter and so would not enter the body during standard procedure; per standard procedure, catheter tract is smaller than stress relief diameter, as stress relief is larger than catheter tubing.Additional information indicates that catheter had moved out of initial placement in kidney, cause unknown.Patient's underlying condition may have contributed to the incident described in this report.Uresil is unable to determine from the information provided why the stress relief detached from the hub in this case.No remedial action/corrective action/preventive action is required as a result of this report.Uresil does not believe this incident represents a serious injury.Additionally, uresil has received only this one report of this failure mode out of hundreds of thousands of catheters with the adhesive-lined stress relief.A review of uresil's risk management files indicates that "stress relief detaches" is considered a critical risk, in other words, with the potential for injury or clinical intervention.In the incident described in the referenced report, the doctor's inaction with respect to the incident is in line with uresil's assessment that the incident did not cause a serious injury.Device not available for evaluation.
Event or Problem Description
Incident occurred (b)(6) 2016 and was reported to uresil distributor by (b)(6) report on 2016-11-25.Uresil received report 2016-11-29.From information provided in the original report and additional information provided by our distributor, we have gathered that the physician was advised by patient's family that the stress relief, or blue collar under [distal to] the hub, detached from the hub and migrated down the shaft of the catheter to the pigtail, where it was stopped by the suture/locking mechanism and became lodged under the patient's skin.Physician determined based on patient condition that no action was required.Report indicates that the patient developed cellulitis and discharge at the wound site; it is unclear the reason for the infection at the wound site.The stress relief later came out of the catheter insertion site and was discarded.

• Brand Name: TRU-SET NEPHROSTOMY CATHETER
• Common Device Name: NEPHROSTOMY CATHETER
• Manufacturer (Section D): URESIL, LLC; 5418 w touhy ave; skokie IL 60077
• MDR Report Key: 6211566
• Report Number: 1450395-2016-00001
• Device Sequence Number: 18948662
• Product Code: GBO
• UDI-Device Identifier: H862NCL20835HB0
• UDI-Public: H862NCL20835HB0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 12/26/2016

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?: Yes
• Operator of Device: Physician
• Device Expiration Date: 07/31/2017
• Device Model Number: NCL2-0835HB
• Device Catalogue Number: NCL2-0835HB
• Device Lot Number: 5G631
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2016
• Initial Report FDA Received Date: 12/28/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other