MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET; FAD, STENT, URETERAL

Catalog Number RMS-060024-R

Device Problem Partial Blockage (1065)

Patient Problems Fever (1858); Blockage (2332)

Event Date 03/27/2014

Event Type  Injury  

Event Description

A female pt with ureteral obstruction had been using polymer stents for the past 2 years, with the doctor changing the stents every 3 months.The doctor had heard that resonance stents (rms) can be used for 1 year and thus decided to use it.The rms stent was placed in the pt's right kidney on (b)(6) 2014.The pt returned to the hospital on (b)(6)2014 with a fever and she could not pass urine.The doctor used an ultrasound and injected contrast was not visible indicating the rms stent was blocked.The doctor decided to remove the rms stent and replaced it with a normal polymer stent (optima).No further adverse effect to the pt were reported as occurring.

Manufacturer Narrative

The customer reported the following complaint issue: a female pt with ureteral obstruction had been using polymer stents for the past 2 years, with the doctor changing the stents every 3 months.The doctor had heard that resonance stents (rms) can be used for 1 year and thus decided to use it.The rms stent was placed in the pt's right kidney on (b)(6) 2014.The pt returned to the hospital on (b)(6) 2014 with a fever and she could not pass urine.The doctor used an ultrasound and injected contrast was not visible indicating the rms stent was blocked.The doctor decided to remove the rms stent and replaced it with a normal polymer stent (optima) and the pt has reported no further issues.One x resonance stent of lot # c903574 was returned to cook ireland for evaluation.The device was not returned in its original packaging.On evaluation of the returned resonance device by the relevant cirl engineer, the stent was noted to be the correct shape.It was confirmed that the rms stent was an rms-060024-r.No kinks or marks were visible on the sent.There were no signs of encrustation present on the stent.When the stent was examined under the microscope there was no sign of blockage within the coils of the stent.The internal driver wire was present and no issue was noted with the drive wire.There was no visual issue observed that could have caused the stent not to function as intended.No fault or defects were noted with the returned stent.A definitive cause for the reported observation could not be determined because the actual use condition could not be duplicated in the laboratory setting.Due to a variety of clinical conditions such as pt anatomy or progression of disease state, cook ireland could not reproduce the actual conditions of device usage.Therefore the complaint is considered confirmed as reported by the customer as it was not possible to conclusively determine that the device did not fail to use.As per instructions for use, removal or replacement of a resonance stent is standard procedure.Potential adverse events associated with indwelling ureteral stents include diminished urine drainage.A warning on the instructions for use, advised the following: "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Use of this device should be based upon consideration of risk-benefit factors as they apply to your pt.Informed consent should be obtained to maximize pt compliance with follow-up procedures." a final warning indicates that: "individual variations of interaction between stents and the urinary system are unpredictable." prior to distribution all resonance stent device are subject to visual inspections to ensure device integrity.A review of the manufacturing records for lot number c903574 did not reveal any discrepancy related to this complaint issue.Quality engineering will continue to monitor complaints of this nature for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD, STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: tract o'sullivan ; 61334440
• MDR Report Key: 3784186
• MDR Text Key: 4360941
• Report Number: 3001845648-2014-00071
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2014

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/05/2016
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C903574
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/07/2014
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/27/2014
• Event Location: Hospital
• Initial Date Manufacturer Received: 04/09/2014
• Initial Date FDA Received: 04/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR