MAUDE Adverse Event Report: URESIL, LLC GP GENERAL PURPOSE CATHETER; DRAINAGE CATHETER

Model Number	GPL2-0830H
Medical Device Problem Codes	Detachment Of Device Component (1104); Migration or Expulsion of Device (1395)
Health Effect - Clinical Codes	Staphylococcus Aureus (2058); Foreign Body In Patient (2687)
Date of Event	05/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The stress relief has an adhesive lining that would make it difficult to move off the tubing, and it is shrunk to the diameter of the catheter during manufacturing.Only the stress relief portion of the device was returned to uresil for evaluation; the rest of the device was discarded following the initial drainage procedure.Uresil is unable to determine from the information provided why the stress relief detached from the hub, as the adhesive lining was present.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.We have reviewed the manufacturing records for both lots 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.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 catheter before being subjected to a 100% leak test.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 only received one other report of the stress relief becoming lodged in the body since the implementation of adhesive-lined stress reliefs in mid-2012; uresil has sold (b)(4) of catheters containing the adhesive-lined stress relief in that time.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.The clinician's statement that the incident was not life-threatening and did not lead to permanent impairment is in line with uresil's assessment that the incident did not cause a serious injury.
Event or Problem Description
Stress relief was discovered as having been retained in the patient's renal pelvis during a ultrasound; stress relief was subsequently successfully removed through surgical intervention on or shortly before (b)(6) 2018.Stress relief was determined by hospital to have been related to a nephrostomy drainage procedure between (b)(6) 2017 using a uresil gpl2-0830h.Based on shipment records, the uresil distributor and hospital believe the product to be lot 6f494 or 6h652.

• Brand Name: GP GENERAL PURPOSE CATHETER
• Common Device Name: DRAINAGE CATHETER
• Manufacturer (Section D): URESIL, LLC; 5418 w touhy ave; skokie IL 60077
• MDR Report Key: 7584451
• Report Number: 1450395-2018-00001
• Device Sequence Number: 178486
• Product Code: GBO
• UDI-Device Identifier: H862GPL20830H0
• UDI-Public: H862GPL20830H0
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 06/30/2019
• Device Model Number: GPL2-0830H
• Device Catalogue Number: GPL2-0830H
• Device Lot Number: 6F494 OR 6H652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/08/2018
• 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
• Patient Age: 76 YR