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

Catalog Number RMS-060026-R

Device Problem Migration or Expulsion of Device (1395)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted following the completion of the investigation.

Event Description

The stent that was placed in the patient migrated distally.The stent was removed and exchanged without incident.This is related to 3001845648-2016-00351 and 3001845648-2016-00353.

Manufacturer Narrative

The complaint device was not available for return to cirl for a lab evaluation therefore a documentation based investigation was carried out.The lot number of the rms060026-r device involved in this complaint is unknown therefore a review of the manufacturing records could not be completed.The complaint was confirmed based on the customers 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 as the device was not returned.Prior to distribution, resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.The rms-060026-r 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 instructions for use, stent migration is listed as a potential adverse event associated with indwelling ureteral stents.As per instructions for use , users are cautioned as follows: ¿individual variations of interaction between stents and the urinary system are unpredictable.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 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).¿ a final warning indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.

Event Description

This is a follow up report following the completion of the investigation.The stent that was placed in the patient migrated distally.The stent was removed and exchanged without incident.This is related to 3001845648-2016-00351 & 3001845648-2016-00353.

• 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: 6134693
• MDR Text Key: 61143926
• Report Number: 3001845648-2016-00352
• 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
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2016
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 11/02/2016
• 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