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

Catalog Number UNKNOWN

Device Problem Material Erosion (1214)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

(b)(6) 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 patient anatomy or progression of disease state, cook ireland could not reproduce the actual conditions of device usage.The device involved in the complaint was not available to be returned for evaluation.With the information provided a document based investigation was carried out.Prior to distribution, resonance stent devices are subjected to visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in the procedures referenced above and attached.As the lot number of the device involved in this complaint was not provided, it was not possible to conduct a review of the device manufacturing records for this device.As per instructions for use , ifu0020-14,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, ifu0020-14, 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".Customer quality assurance will continue to monitor complaints of this nature for potential emerging trends.

Event Description

The resonance stent was placed approximately 6 months ago at (b)(6).The rep was at a different hospital and spoke with a physician who works at several hospitals, one of which is (b)(6).This physician commented in passing that a partner physician at (b)(6) had told him that a resonance metallic ureteral stent had to be removed from a patient due to ureteral pelvic junction erosion.He did not know if the stent was the cause of the erosion nor does he know how the patient was treated.The rep tried to gather as much information as possible but this was all that the physician knew.

• 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: 5453845
• MDR Text Key: 38778398
• Report Number: 3001845648-2016-00041
• 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: Other
• Type of Report: Initial
• Report Date: 01/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Manufacturer Received: 01/27/2016
• 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