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

Catalog Number RMS-060024-R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Type  Injury  

Manufacturer Narrative

1 x rms-060024-r of lot c1177171 was returned to cirl for a lab evaluation.Upon analysis of the returned device, there was very little encrustation noted on the stent, the stent did not appear to have any defects that could have contributed to this event, the stent was cut open on either end and a guidewire was passed through to determine if there was any blockage that may have contributed to the pain felt by the customer; there was no blockage found; the guidewire passed through the stent.It was noted during the evaluation that pain is listed as a potential adverse effect of stent placement as individual stent-body interactions are unpredictable.There was no anomaly found on the stent that could have contributed to this event.The stent was placed for three months which is within the recommended in-dwelling timeframe of 12 months.This device was used in a case of ureterostomy.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.It is possible that this event was attributed to the use of the stents in a patient with ureterostomies, however this cannot be conclusively determined.The customers complaint was confirmed based on customer testimony.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 ifu0020-14 state the following in the ¿warnings¿ section: ¿individual variations of interaction between stents and the urinary system are unpredictable¿ and " the use of this device should be based upon consideration of risk/ benefit factors as they apply to your patient" and "patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage." the customer was asked if the patient was using calcium supplementation; however to date, it is unknown if the patient was using calcium supplementation.Potential adverse events associated with indwelling ureteral stent listed on the ifu include: pain / discomfort.Diminished urine drainage/ stent occlusion.Stent encrustation.Hydronephrosis.Pyuria (due to infection).A review of the relevant manufacturing records for the rms-060024-r device of lot c1177171 did not reveal any discrepancies that could be related to this occurrence.There is no evidence to suggest that this issue affects the entire lot # c1177171; upon review of complaints this failure mode has not occurred previously with this lot # c1177171.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

As reported to customer relations: "two resonance stents were placed in the patient on (b)(6) 2016.The patient complained of discomfort and pain so the stents were removed on (b)(6) 2016.It is unknown how long the patient experienced the discomfort." reference also related report # 3001845648-2016-00338.

• 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: 6128795
• MDR Text Key: 60930743
• Report Number: 3001845648-2016-00339
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)181201(10)C1177171
• 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
• Report Date: 10/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060024-R
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/01/2016
• Initial Date FDA Received: 11/28/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2015
• 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