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

Catalog Number RMS-060024-R

Device Problem Occlusion Within Device (1423)

Patient Problem Occlusion (1984)

Event Date 09/07/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned to cirl for a lab evaluation and there were no photographs provided by the customer therefore a documentation based investigation was carried out.The customers complaint was confirmed on customer testimony.The customer stated in the additional information received that it is unknown if the device caused the obstruction and the device was removed as a precautionary measure.A definitive root cause of this complaint could not be conclusively determined as device use, anatomical conditions and storage and transport conditions could not be replicated.It should be noted that the instructions for use states the following in the ¿warnings¿ section: ¿individual variations of interaction between stents and the urinary system are unpredictable¿ and "change in urine viscosity may hamper drainage" and "diminished urine drainage/ stent occlusion" is listed as a potential adverse event associated with the indwelling ureteral stent, the ifu also states that " the use of this device should be based upon consideration of risk/ benefit factors as they apply to your patient" a review of the relevant manufacturing records for the rms-060024-r device could not be performed as the lot number was not provided.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

The physician reached out to the rep to report that a patient, which they had placed a resonance stent in, had come back to the er with an obstruction.The physician was unsure if the stent was the cause of the obstruction but let the rep know about it anyway.The stent was removed.

• 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: 5995940
• MDR Text Key: 56333062
• Report Number: 3001845648-2016-00285
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 09/07/2016

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-060024-R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/07/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/09/2016
• Initial Date FDA Received: 10/04/2016
• 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