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 Problems Calcium Deposits/Calcification (1758); Occlusion (1984)

Event Date 10/27/2016

Event Type  Injury  

Manufacturer Narrative

As of 16/nov/2016 the complaint device has not yet been received at cirl for a lab evaluation; therefore a documentation based investigation has been carried out.The complaint file will be updated with the lab evaluation findings upon receipt of the complaint device.The customers complaint was confirmed based on customer testimony.The stent involved in this complaint was in dwelling for approximately five months.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 state 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".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" 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: * 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 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 stent had calcified and blocked the kidney.The stent was replaced.

Manufacturer Narrative

The customer complaint device was received at cirl.The stent was found to be encrusted with a large calcium deposit/ stone on the end of the pigtail.The engineers in the lab evaluation noted that encrustation is patient related and not device related.The stent was snipped at either end and encrustation was visible inside at the potential point of contact with the bladder and kidney.The encrustation may have caused the blockage in the kidney with may have resulted in pain.The stent involved in this complaint was in dwelling for approximately five months.A definitive root cause of this complaint could not be conclusively determined as anatomical/physiological conditions could not be replicated; however this occurrence is most likely attributed to patient physiology.It should be noted that the instructions for use state 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".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" 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: 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 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

A follow-up mdr is being submitted to include the device evaluation details.The stent had calcified and blocked the kidney.

• 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: 6123663
• MDR Text Key: 60747442
• Report Number: 3001845648-2016-00337
• 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,Followup
• Report Date: 11/22/2016

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?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/27/2016
• Event Location: Hospital
• Initial Date Manufacturer Received: 10/27/2016
• Initial Date FDA Received: 11/23/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/20/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 82 YR