MAUDE Adverse Event Report: COOK IRELAND LTD RESONANCE STENT SET

Catalog Number RMS-060024-R

Device Problem Occlusion Within Device (1423)

Patient Problems Urinary Retention (2119); Surgical procedure, additional (2564)

Event Date 06/27/2015

Event Type  Injury  

Event Description

On (b)(6) 2015: the device was placed in the urinary duct transurethrally to treat ureteral stricture due to cancer of uterine body.The pt had had another mfr's polyurethane stent (inray optima/by bard) placed previously and it had been regularly (every two months) changed with another polyurethane stent.The resonance stent was selected in consideration of prognosis because a frequency of changing stent would be reduced.She was an ambulatory pt with no urinary-tract infection.On (b)(6) 2015: the pt came to the hospital urgently as an outpatient.The physician found that urine was not draining and decided to retrieve the resonance since it would be risky to keep the occluded stent placed.After retrieval of the stent, another mfr's polyurethane stent (inray optima/ by bard)was placed.Though the physician referred the pt to a hospital for admission, she refused and went back home.On (b)(6) 2015: the replaced stent drains well.There have been no adverse effects reported.There have been no further adverse effects reported.

Manufacturer Narrative

Incident meets reporting criteria of an fda mdr report as the removal and replacement of the rms stents is viewed as surgical intervention to prevent a serious injury.No device malfunction has been reported, the device not draining is interpreted as a performance related issue.A 1 x rms-060024-r device of lot# c1101298 was returned for eval.Our eval of the returned resonance device the stent was noted to be the correct shape.There were no signs of encrustation or blockages present within the coils on the stent when they were examined visually by the cirl senior mfg engineer.The wells of both ends of the stent were cut off.The safety wire was present and intact.A wire guide was passed through the stent and no resistance or blockages were noted.The complaint was confirmed based on the customer testimony.A definitive cause for the customer's complaint was unable to be determined because the actual use conditions 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.Prior to distribution all rms-060024-r devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections are outlined in internal procedures in place at cirl.A review of the relevant mfg records revealed no discrepancies related to this complaint issue.As per the instructions for use that accompanies this device: "resonance stent devices are used for temporary stenting of the ureter in adult pts with extrinsic ureteral obstruction.These devices are intended for one-time use."as per instructions for use removal or replacement of a resonance stent is standard procedure.Also, as per instructions for use, 'potential adverse events associated with indwelling ureteral stents include diminished urine drainage/stent occlusion and hydronephrosis'.A warning on the instructions for use, advises the following: "pts 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".In this incident the physician indicated that he believed the pt was suitable for the procedure.The procedure was successful and conducted with no problem.The physician could not determine the cause that the stent stopped draining on the third day after stent placement.Complaints of this nature will continue to be monitored for potential emerging trends.

• Brand Name: RESONANCE STENT SET
• Manufacturer (Section D): COOK IRELAND LTD; limerick ; EI
• Manufacturer Contact: sinead quaid, sr reg aff special ; limerick ; EI ; 61334440
• MDR Report Key: 4941992
• MDR Text Key: 6639576
• Report Number: 3001845648-2015-00150
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Unknown
• Type of Report: Initial
• Report Date: 06/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2018
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C1101298
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/27/2015
• Event Location: Hospital
• Date Manufacturer Received: 07/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2015
• 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