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

Catalog Number RMS-060022-R

Device Problems Fracture (1260); Difficult to Remove (1528); Use of Device Problem (1670)

Patient Problems 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.General questions for all complaints: what are the current storage conditions? are the stents stored in their boxes? unkr, implant facility not known.Did the device make patient contact? yes.Once the device comes in contact with the patient, request the following for 3 previously mentioned prefixes: did anything have to be removed from the patient? yes.If yes, from what part of the body and what instrument was used to remove it? kidney and ureter, flexible graspers.Current storage conditions.Unkr, implant facility not known.Why was the stent removed? (exchange? or other issue?) -exchange.What was the length of the indwell time? 12 months.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? n/a.What wire guide did they use? hydrophylic wire did they attempt to attach the tapered end of the stent to the inserter? n/a.Was this device assembled outside the body? n/a.Did the device come with a pigtail straightener? n/a.If yes, was the pigtail straightener used? n/a.Request the following should the complaint be regarding difficulty with the hydrophilic coating (wire guide): n/a.Should the event involve metallic resonance (rms) stents, request the following: was the stent stored in strong light (e.G.In a pyxis maching) or in direct sunlight? unkr, implant facility not known.Was there difficulty advancing the stent to the target location? n/a.How long was the stent in-dwelling? 12 months.What was used to remove the stent? flexible grasper.How often was the stent checked during the in-dwelling time? physician did not know.What method was used? unkr.Was the patient using calcium supplementation? unkr.Was force required to remove the stent? yes, a little bit.Was encrustation evident on the stent? yes, a lot.What is the source of the extrinsic compression? pt anatomy.If caused by a tumor, what is the tumor type? no tumor.What is the stage of the tumor? n/a.Per rep - 15oct2020 - can it please be confirmed what exact date the stents were placed, it just says 12 months prior? stents were placed (b)(6) 2019.Also how often was the patient monitored within this 12 month indwell period and by what methods please? patient had a couple ct scans for urinary tract infections, but due to covid the 6 month change was delayed to 12 months due to patient caregiver¿s decision.What is the patient's condition now? (b)(6) has not heard from the patient and expects them to be doing well.It is mentioned "they did not have consent from the patient's guardian for percutaneous techniques." how is the patient's condition managed after the stent removal? percutaneous consent wasn¿t provided at the time of the extraction procedure.However, following the stent extraction consent was obtained.The patient was then hospitalized overnight and perc¿ed the next morning for neph tube placement.Did any unintended section of the device remain inside the patient¿s body? no.If yes, please describe.Was the patient hospitalized or was there prolonged hospitalization? no.Did the patient require any additional procedures due to this occurrence? no.If yes, please describe.This new file was created to capture the second stent where the stent wire snapped.A sperate file is capturing the difficult removal of the first stent.

Manufacturer Narrative

Device evaluation: the rms-060022-r device of an unknown lot involved in this complaint was not available 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 all rms-060022-r devices are subject to visual a visual inspection and functional checks to ensure device integrity.These inspections and functional checks are outlined in internal procedures in place at cirl.It should be noted that the instructions for use (ifu0020-18) 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 removed if encrustation hampers drainage¿.Instructions of use also mention: "the stent must not remain indwelling more than 12 (twelve) months.If patient's status permits, the stent may be replaced with a new stent".The instructions of use also warn for potential adverse events "potential adverse events associated with indwelling ureteral stents include: stent encrustation" there is sufficient evidence to suggest the user did not follow the ifu.Per the event notes placed (b)(6) 2019, removed (b)(6) 2020.A definitive root cause could be attributed exceeded indwell period per event notes- placed (b)(6) 2019, removed (b)(6) 2020.It should be noted as per the customer input there was a lot of encrustation evident on the stent, it could be possible this contributed to the snapped wire.Note the patient was monitored during stent indwell patient had a couple ct scans for urinary tract infections, but due to covid the 6 month change was delayed to 12 months due to patient caregiver¿s decision.Summary: the complaint is confirmed based on customer testimony.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Supplemental report is being submitted due to the completion of the investigation.

• 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 10718197
• MDR Text Key: 216662267
• Report Number: 3001845648-2020-00808
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/07/2022

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
• Supplement Dates FDA Received: 04/04/2022
• 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