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

Model Number G34112

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

Patient Problems Obstruction/Occlusion (2422); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/19/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6) 2023 rms-060028-r was placed in a renal pelvis of a patient with ureter stenosis.(b)(6) 2023 the user observed the tip of the stent was caught in the upper urinary tract under fluoroscopy, so he determined that it would be difficult to remove, and the operation was discontinued.At a later date, it will be removed transurethrally or percutaneously under general anesthesia.Additional information on (b)(6) 2023 rms-060028-r placed date: (b)(6) 2023, (b)(6) 2022.Patient outcome: at a later date, it will be removed transurethrally or percutaneously under general anesthesia.User's comment: the tip of the stent may have migrated into the upper urinary tract, or the calculus may have prevented the pigtail from straightening out.Patient/event info - note; [additional information].For complaints observed during device preparation, ask: was the package damaged? questions for metallic resonance (rms) stents: are any images available for review? none.What was the target location for the stent? renal pelvis.Did anything have to be removed from the patient? no.If yes, please specify: what part of the body the device was removed from? what device was removed? what instrument was used to remove it? please specify the storage conditions of the device at the facility, particularly those relating to light, temperature and where(location).Why was the stent removed? (exchange? or other issues?) exchange.If other, please detail why the stent was removed.If the stent was removed what was used to complete the procedure? what was the length of the indwell time? what disease mode was the physician trying to treat? what wire guide did they use? did the device come with a pigtail straightener? yes.If yes, was the pigtail straightener used? yes.Did the user attempt to attach the stent to the inserter before or after wire guide insertion? yes (after).Did they attempt to attach the tapered end of the stent to the inserter? n/a for resonance stent.Was this device assembled outside of the body? yes.Was there difficulty advancing the stent to the target location? no.How often was the stent checked during the in-dwelling time? what method was used? yes.Was the patient using calcium supplementation? yes.Was force required to remove the stent? yes.Was encrustation evident on the stent? unknown.What is the source of the extrinsic compression? if caused by a tumor, what is the tumor type? what is the stage of the tumor? did the patient require any additional procedures as a result of this event? n/a, yes, no yes.What intervention (if any) was required? at a later date, it will be removed transurethrally or percutaneously under general anesthesia.Was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? n/a, same procedure, another day another day.Were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no no.If yes, please specify what was observed and where on the device it was observed.

Event Description

Supplemental report is being submitted due to the completion of the investigation on 12-jan-2024.

Manufacturer Narrative

Device evaluation: the rms-060028-r device of lot number c1751197 involved in this complaint was not available for evaluation.With the information provided, a document-based investigation was conducted.Lab evaluation: the device evaluation could not be completed as the device or photographic evidence of the device was not returned for evaluation.Manufacturing records: prior to distribution all rms 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.Review of historical data a review of the manufacturing records for rms-060028-r of lot number c1751197 did not reveal any discrepancies that could have contributed to this complaint issue.The review of relevant manufacturing records confirms the failure mode has not previously occurred with the current lot number.Based on the information available to date, there is no evidence to suggest that there are any manufacturing issues associated with lot number c1751197.It should be noted that the instructions for use, ifu0020, states the following: ¿the stent must not remain indwelling more than 12 months.¿ the ifu also states ¿use with wire guide with 0.038¿ diameter¿ there is evidence to suggest that the customer did not follow the instructions for use.The japanese packaging insert (uro-p034-s17-r02) supplied with the device complies with mhlw law no.84 of 2013 which avoids including information that is not specific to the medical device or that which is basic knowledge already understood by the healthcare professional, to ensure to accurately convey all the information that is important for the user.Image review an image was not returned for evaluation.Root cause analysis: definitive root cause of user error can be identified.From customers testimony it is known the resonance stent device was indwelling greater than 12 months it was attempted to be removed after 13 months.It is also known that incorrect wireguide was used a 0.035 inch wireguide was used but as per engineering input these incidents could both be related to difficulty removing the stent and will be captured under this complaint.Confirmation of complaint: complaint is confirmed based on customer and/or rep testimony.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: according to the customer the devices were left indwelling greater than 12 months.Complaint is confirmed based on customer and/or rep testimony.A root cause of user error has been identified.According to the initial reporter, the patients required surgical intervention.Complaints of this nature will continue to be monitored for potential 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: 17142317
• MDR Text Key: 317452449
• Report Number: 3001845648-2023-00468
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 01/12/2024

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 Expiration Date: 08/14/2023
• Device Model Number: G34112
• Device Catalogue Number: RMS-060028-R
• Device Lot Number: C1751197
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/22/2023
• Initial Date FDA Received: 06/16/2023
• Supplement Dates Manufacturer Received: 05/22/2023
• Supplement Dates FDA Received: 02/08/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/14/2020
• 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 Sex: Female