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

Model Number G34110

Device Problems Difficult to Remove (1528); Failure to Advance (2524); Dent in Material (2526)

Patient Problems Unspecified Kidney or Urinary Problem (4503); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/23/2023

Event Type  Injury  

Event Description

Transurethral ureteral stent placement.The product was deformed, so the user used another same product (unknown lot#) to complete the procedure.Updated on (b)(6) 2023: primary disease: lung cancer, ureteral stricture due to intra-abdominal metastasis, hydronephrosis resonance was already in place in the right ureter, and the left was also stenotic.This time, rms-060024-r was attempted to be planned for the left ureter.Rp with urinary catheter was fine, and when the user attempted to insert the introducer of rms-060024-r, it was a little tight.When the introduction catheter was removed and the rms was inserted to be placed, it was caught in the middle and could not be placed.Since it was not possible to pull out the rms, when the whole was pulled out, it was deformed around 10 cm from the tip of the sheath.A polymer stent (manufacturer unknown) was placed and the procedure was completed.Images not provided.No health hazard.2 questions for metallic resonance (rms) stents: 1 are any images available for review? pls.Refer patient/event info tab.2 what was the target location for the stent? 3 did anything have to be removed from the patient? 4 if yes, please specify: 5 (i) what part of the body the device was removed from? 6 (ii) what device was removed? 7 (iii) what instrument was used to remove it? 8 please specify the storage conditions of the device at the facility, particularly those relating to light, temperature and where(location).9 why was the stent removed? (exchange? or other issues?) 10 if other, please detail why the stent was removed.11 if the stent was removed what was used to complete the procedure? 12 what was the length of the indwell time? 13 what disease mode was the physician trying to treat? 14 what wire guide did they use? 15 did the device come with a pigtail straightener? 16 if yes, was the pigtail straightener used? 17 did the user attempt to attach the stent to the inserter before or after wire guide insertion? 18 did they attempt to attach the tapered end of the stent to the inserter? n/a for resonance stent 19 was this device assembled outside of the body? 20 was there difficulty advancing the stent to the target location? 21 how often was the stent checked during the in-dwelling time? 22 what method was used? 23 was the patient using calcium supplementation? 24 was force required to remove the stent? 25 was encrustation evident on the stent? 26 what is the source of the extrinsic compression? 27 if caused by a tumor, what is the tumor type? what is the stage of the tumor? 28 did the patient require any additional procedures as a result of this event? n/a, yes, no 29 what intervention (if any) was required? 30 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 31 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? n/a, yes, no 32 if yes, please specify what was observed and where on the device it was observed.

Manufacturer Narrative

Pma/510(k) # k063742.Investigation is still pending, a follow up mdr will be submitted to include the investigation conclusions.

Event Description

Supplemental report is being submitted due to the completion of the lab evaluation on 29-jun-23.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the update answers to additional question on 02-oct-23 (see below) - lab evaluation notes wording also updated on 03-oct-23 (see section 6 relevant tests/lab data for update).(b)(6) 2023: - what happened to the stent that was attempted to be placed ? ¿the whole system was pulled out.1 for complaints observed during device preparation, ask: 1-1 was the package damaged? no.2 questions for metallic resonance (rms) stents: 1 are any images available for review? no.2 what was the target location for the stent? urinary duct.3 did anything have to be removed from the patient? no.4 if yes, please specify: 5 (i) what part of the body the device was removed from? 6 (ii) what device was removed? 7 (iii) what instrument was used to remove it? 8 please specify the storage conditions of the device at the facility, particularly those relating to light, temperature and where(location).It was stored vertically on a shelf in the operating room.9 why was the stent removed? (exchange? or other issues?) other 10 if other, please detail why the stent was removed.New placement, so there was no stent removed.11 if the stent was removed what was used to complete the procedure? 12 what was the length of the indwell time? 13 what disease mode was the physician trying to treat? ureteral stricture, hydronephrosis.14 what wire guide did they use? boston scientific/sensor.15 did the device come with a pigtail straightener? yes.16 if yes, was the pigtail straightener used? yes.17 did the user attempt to attach the stent to the inserter before or after wire guide insertion? yes (after).18 did they attempt to attach the tapered end of the stent to the inserter? n/a for resonance stent.19 was this device assembled outside of the body? no.20 was there difficulty advancing the stent to the target location? yes.21 how often was the stent checked during the in-dwelling time? 22 what method was used? yes.23 was the patient using calcium supplementation? unknown.24 was force required to remove the stent? new.Placement, so there was no stent removed.25 was encrustation evident on the stent? new placement, so there was no stent removed.26 what is the source of the extrinsic compression? lung cancer, intra-abdominal metastasis.27 if caused by a tumor, what is the tumor type? what is the stage of the tumor? lung cancer, intra-abdominal metastasis.28 did the patient require any additional procedures as a result of this event? no 29 what intervention (if any) was required? 30 was the secondary intervention performed during the same procedure as the device failure or was it scheduled for another day? 31 were any other defects (other than the complaint issue) observed on the device prior to return (e.G.Kink)? no 32 if yes, please specify what was observed and where on the device it was observed.

Manufacturer Narrative

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

Event Description

Supplemental report is being submitted due to the completion of the investigation on 21-feb-2024.

Manufacturer Narrative

Device evaluation: 1 x rms-060024-r of lot number: c2007388 was returned to cirl for evaluation.Lab evaluation: the device involved in the complaint was evaluated in the laboratory on 29th june 2023.The returned device lab findings and observations can be referred through the attached files.Visual inspection: introducer sheath returned, introducer sheath compressed on both ends, kink observed on the introducer sheath 14cm from the hub.Following the lab eval additional information was requested.From additional information provided: ¿just wondering please for (b)(4) ¿deformation of introducer sheet¿ did we get a response to the standard list of questions for this complaint please ? the user attempted to insert and place rms in the left ureter with usual procedure.But rms was caught in the middle and he couldn't push and pull the stent, so he removed pulling out the whole.Also please note a kink was observed on the returned device in the lab could you ask please if this was observed during the procedure ? doctor¿s comment: (when asked if there were any unusual concerns at the time of the defect, without mentioning the kink,) there were no particular concerns.Rep¿s comment: i don't have the information where was kinked, it is possible that the kink may have been caused by excessive force when the stent got stuck.Based on the above user's comments, it is believed that there was no kinking prior to use.Functional inspection: n/a.Prior to distribution rms-060024-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.A review of the manufacturing records for rms-060024-r of lot number: c2007388 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: c2007388.Review historical data: the instructions for use, ifu0020 which accompanies this device instructs the user to ¿visually inspect with particular attention to kinks, bends and breaks.If an abnormality is detected that would prohibit proper working condition, do not use.¿ the japanese packaging insert (uro-p034-s17-r05) supplied with the device states ¿if resistance is encountered during the operation , stop the operation and determine the cause of the resistance.Forceful operation may result in damage to device and tissues.¿ there is no evidence to suggest the user did not follow the ifu.(ifu0020).Image review: an image was not returned for evaluation.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.A possible root cause could be attributed to patients¿ anatomy, from customer feedback it is know when they tried to advance the introducer it was a little tight.The compression and kink observed on the introducer sheath observed in the lab could be in relation to tight patient anatomy.Additionally, a possible root cause could be attributed to the deformation of introducer due to excessive pressure being applied to the device as it was attempted to insert the introducer into position.It may be noted, as per rep¿s comment provided ¿i don't have the information where was kinked, it is possible that the kink may have been caused by excessive force when the stent got stuck.Based on the above user's comments, it is believed that there was no kinking prior to use.¿ confirmation of complaint: complaint is confirmed based on visual and/or functional inspection.Corrective action/ correction: complaints of this nature will continue to be monitored for similar events.Summary of investigation: according to the customer the introducer sheath was deformed.Complaint is confirmed based on visual and/or functional inspection.A possible root cause could be attributed to patients anatomy.According to testimony the patient suffered no adverse event due to this occurrence complaints of this nature will continue to be monitored for similar events.

• 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: 17182318
• MDR Text Key: 317819417
• Report Number: 3001845648-2023-00495
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• 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,Followup,Followup
• Report Date: 02/21/2024

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 Model Number: G34110
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C2007388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/23/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/24/2023
• Initial Date FDA Received: 06/22/2023
• Supplement Dates Manufacturer Received: 05/24/2023; 05/24/2023; 05/24/2023
• Supplement Dates FDA Received: 07/27/2023; 10/31/2023; 02/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2022
• 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: Male