MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

Patient Problem Pain (1994)

Event Date 06/13/2019

Event Type  Injury  

Manufacturer Narrative

Procode: fad stent, ureteral.

Event Description

According to the journal article: "navetta, 2019 ¿tandem resonance metallic double-j ureteral stents in a single ureter for salvage management of chronic ureteral obstruction¿ complaint #3.Number of devices: 2.Brief description: navetta 2019 - ¿flank pain." description of event: flank pain.Patient outcome: patient required nephrostomy.As per table 1 - patient # 4 trs failed due to flank pain and renal failure and was managed by a nephrostomy.As per literature paper; ''in our study, only one patient with metastatic colon cancer was never successfully managed with trs.A pcn was replaced after just 6 days for flank pain, and he died 82 days later.'' medical advisor has confirmed that death is likely related to disease / palliation and not caused / contributed by device' please note: the paper describes the tandem placement of resonance metallic double-j ureteral stents in a single ureter.It goes on to state that seven renal units from four patients were managed with trs.Therefore, as two rms stents were placed simultaneously side by side in 1 renal units for patient #4 that equates to a total of 2 rms stents being placed.Please also note, although we cannot confirm the exact rpn of the resonance metallic double-j ureteral stents used it had the potential to be anyone if the following: rms-060012-r, rms-060014-r, rms-060016-r, rms-060018-r, rms-060020-r, rms-060022-r, rms-060024-r, rms-060026-r, rms-060028-r, rms-060030-r.This file is created to capture flank pain and renal failure requiring nephrostomy.

• Brand Name: RESONANCE URETERAL STENT METALLIC STENT AND POSITIONER
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 10506857
• MDR Text Key: 206188862
• Report Number: 3005580113-2020-00410
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/08/2020,09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 09/08/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 82 YR