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

Catalog Number RMS-060026-R

Device Problem Occlusion Within Device (1423)

Patient Problems Occlusion (1984); Swelling (2091); Urinary Retention (2119)

Event Date 06/05/2016

Event Type  Injury  

Manufacturer Narrative

The investigation into this event is currently still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.The investigation into this event is currently still in progress.A follow up report will be submitted within 30 days with the investigation conclusions.

Event Description

On (b)(6) 2016: a resonance stent was placed.A urethral balloon catheter was also placed.Urine drainage had been confirmed.On (b)(6) 2016: after removing the urethral balloon catheter, urination stopped.The user confirmed faint hydronephrosis.On (b)(6) 2016: nephrostomy and retrograde angiography were performed.No flow to the urinary bladder was confirmed.While the nephrostomy catheter was placed as well, there was no urine drainage from the urinary bladder side, so the user assumed the resonance stent got occluded.Urine drainage has been confirmed after replacement of the resonance stent with a polyurethane stent.

Manufacturer Narrative

On visual examination of the returned resonance device the stent was noted to be the correct shape and there was no evidence of external encrustation.There were no blockages present within the coils on the stent.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 met.The stent was cut into pieces to allow visual examination of the interior of the stent.There was only a very small amount of encrustation and debris present which was not in sufficient quantity to cause drainage difficulty a definitive cause for the customer¿s complaint of drainage difficulty 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 patient anatomy or progression of disease state, cook ireland could not reproduce the actual conditions of device usage.A possible cause of this complaint may be attributed to patient anatomy however, it is not known if the patient had pre existing medical conditions that may have contributed to this occurrence.The complaint was confirmed based on the customer testimony.Resonance stent devices are used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.These devices are intended for one-time use.As per the 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, advises 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 patient.Informed consent should be obtained to maximize patient 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 devices are subject to visual inspections to ensure device integrity as per internal procedures.A review of the manufacturing records for lot number c1173596 and the affected component did not reveal any discrepancy related to the complaint issue.There is no evidence to suggest that this issue affects the entire lot # c1173596; upon review of complaints this failure mode has not occurred previously with this lot # c1173596.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

This follow up report is being submitted due to the conclusion of the investigation into this event.Initial description submitted as follows: (b)(6) 2016: a resonance stent was placed.A urethral balloon catheter was also placed.Urine drainage had been confirmed.(b)(6) 2016: after removing the urethral balloon catheter, urination stopped.The user confirmed faint hydronephrosis.(b)(6) 2016: nephrostomy and retrograde angiography were performed.No flow to the urinary bladder was confirmed.While the nephrostomy catheter was placed as well, there was no urine drainage from the urinary bladder side, so the user assumed the resonance stent got occluded.Urine drainage has been confirmed after replacement of the resonance stent with a polyurethane stent.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer Contact: sinead quaid ; o'halloran road; national technology park; limerick ; 061334440
• MDR Report Key: 5781903
• MDR Text Key: 49150481
• Report Number: 3001845648-2016-00177
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341118
• UDI-Public: (01)10827002341118(17)181119(10)C1173596
• Combination Product (y/n): N
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 07/11/2016

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060026-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/05/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 06/14/2016
• Initial Date FDA Received: 07/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2016
• Date Device Manufactured: 11/19/2015
• 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