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

Catalog Number RMS-060022-R

Device Problem Difficult to Remove (1528)

Patient Problems Obstruction/Occlusion (2422); No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Per rep: (b)(6) 2020: the stents had been in-dwelling for 12 months.The stents were encrusted so badly that they had to try 5 fr catheters, dual lumen catheters and a rigid cystoscope to dilate.Lastly they had to balloon dilate to remove the stents with flexible graspers.The balloon dilation of the ureters successfully removed the stents.The occluded wire of the second stent snapped and the stent turned into a slinky but was successfully removed.They did not have consent from the patient's guardian for percutaneous techniques.This file was created to capture the difficult removal of the first stent, a separate file has been created to capture the difficult removal and stent wire breakage of the stent.

Event Description

Supplemental follow-up report is being submitted due to the completion of the investigation and an update to the investigation conclusions.

Manufacturer Narrative

1 x rms-060022-r of lot number unknown involved in this complaint was unavailable for return to cirl for evaluation.With the information provided, a document based investigation was conducted.As the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution rms-060022-r devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.The instructions for use, ifu which accompanies this device states the following; ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.It may be noted that according to the instructions for use, instructs the user in step 7: ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿ a final warning in the instructions for use indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿.There is not sufficient evidence to suggest that the user did not follow the ifu.A definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.The root cause of the encrustation may be the result of the patient's anatomical environment and pre-existing conditions.It should be noted that, per the additional information received, as a result of the covid-19 pandemic, the scheduled 6 month change of the device was delayed to 12 months.If the stent was not checked at regular intervals during the indwelling time the encrustation may have become severe enough to cause the difficulty to remove the stent, however given the fact that the stent was not returned for analysis, it is not possible to confirm severe encrustation as the root cause.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation are listed as a complication following the placement of the device.Complaint is confirmed based on the customers testimony.The stent was placed in (b)(6) 2019, after 1 year indwell period during stent replacement, the stent was found to be encrusted and was removed successfully.Patient's condition now is unknown.Complaints of this nature will continue to be monitored for emerging trends.

Event Description

Supplemental follow-up report is being submitted due to corrections made to patient impact coding annex e and annex f on (b)(6)2023.

Manufacturer Narrative

Device evaluation: 1 x rms-060022-r of lot number unknown involved in this complaint was unavailable for return to cirl for evaluation.With the information provided, a document based investigation was conducted.This file is linked to (b)(4) to cover investigation for second stent that snapped during the event lab evaluation: n/a.Image review ¿ n/a.Document review: as the lot number of the complaint stents are unknown, a review of the relevant manufacturing records cannot be conducted.However, prior to distribution rms-060022-r devices are subjected to a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl the instructions for use, ifu (ifu0020-17) which accompanies this device states the following; ¿patients should be checked at regular intervals utilizing techniques such as abdominal x-ray (kub film).Patients using calcium supplements must be more closely monitored for possible stent encrustation.The stent must be removed if encrustation hampers drainage¿.  it may be noted that according to the instructions for use, ifu0020-17, instructs the user in step 7: ¿the stent may be removed using conventional cystoscopic techniques utilizing forceps or grasper.Note: do not force components during removal or replacement.Carefully remove the components if any resistance is encountered.¿   a final warning in the instructions for use indicates that: ¿individual variations of interaction between stents and the urinary system are unpredictable¿   there is not sufficient evidence to suggest that the user did not follow the ifu.Root cause: a definitive root cause could not be determined from the available information.A possible root cause could be attributed to patient condition related.The root cause of the encrustation may be the result of the patient's anatomical environment and pre-existing conditions.It should be noted that, per the additional information received, as a result of the covid-19 pandemic, the scheduled 6 month change of the device was delayed to 12 months.If the stent was not checked at regular intervals during the indwelling time the encrustation may have become severe enough to cause the difficulty to remove the stent, however given the fact that the stent was not returned for analysis, it is not possible to confirm severe encrustation as the root cause.As per instructions for use, diminished urine drainage/ stent occlusion/ stent encrustation are listed as a complication following the placement of the device.Summary: complaint is confirmed based on the customers testimony.The stent was placed in (b)(6) 2019, after 1 year indwell period during stent replacement, the stent was found to be encrusted and was removed successfully.Patient's condition now is unknown.Complaints of this nature will continue to be monitored for emerging trends.

• Brand Name: RESONANCE STENT SET
• Type of Device: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• Manufacturer (Section G): COOK IRELAND LTD; o halloran road; national technology park; limerick
• Manufacturer Contact: sinead o'leary ; o halloran road; national technology park; limerick
• MDR Report Key: 10720549
• MDR Text Key: 215480208
• Report Number: 3001845648-2020-00809
• 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: User Facility,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/15/2023

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: RMS-060022-R
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/23/2020
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/23/2020
• Initial Date FDA Received: 10/22/2020
• Supplement Dates Manufacturer Received: 09/23/2020; 09/23/2020
• Supplement Dates FDA Received: 06/18/2021; 12/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: 27 YR
• Patient Sex: Male