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

Catalog Number RMS-060024-R

Device Problems Break (1069); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/22/2023

Event Type  Injury  

Manufacturer Narrative

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

Event Description

There was a kink so the wire cannot pass through.Did any section of the device remain inside the patient¿s body? no did the patient require any additional procedures due to this occurrence? no did the product cause or contribute to the need for additional procedure(s)? no has the complainant reported any adverse effects on the patient due to this occurrence? no has the complainant reported that the product caused or contributed to the adverse effect(s)? no the resonance stent can't be deployed due to the kink.So, they need to use grasper to pull the whole thing out (the returned faulty product) from patient body.There was nothing left inside patient¿s body.

Event Description

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

Manufacturer Narrative

Device evaluation: 01 x rms-060024-r of lot c1970483 was returned to cirl opened in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.Device photos and video provided show the device in packaging, it is not clear from the photos and videos where the kink is.03 attempts for additional information were made unsuccessfully.Should information be returned upon completion of the investigation, this file will be reopened and updated accordingly.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation.Visual inspection: stent and introducer returned.Introducer has kink/compressed just after the end of the stent in the tube.Stent is fully inside introducer.Functional inspection: kink observed approximately 17.5 cm from the introducer tip.Manufacturing records: 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.Review historical data: a review of the manufacturing records for rms-060026-r of lot number c1970483 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 c1970483.It should be noted that the instructions for use (ifu0020) states the following: ¿improper handling of the stent prior to insertion into the ureter may harm the functionality of the stent.Bending, stretching or any other type of improper handling may deform the stent.It is important that stent is handled with care¿."with introduction catheter and sheath in proper position, remove introduction catheter to allow passage of stent".There is no evidence to suggest the user did not follow the ifu.Image review: n/a.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As there is limited information provided, a potential root cause is difficult to ascertain.Based on the information to date, a possible root cause could be attributed to the introducer becoming kinked due to excessive pressure being applied to the device as it was attempted to be advanced into position.Confirmation of complaint complaint is confirmed based on the visual and/or functional inspection.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: complaint is confirmed based on the visual and/or functional inspection.Failure identified: introducer kinked - 01 device confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device was removed successfully with graspers.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As there is limited information provided, a potential root cause is difficult to ascertain.Based on the information to date, a possible root cause could be attributed to the introducer becoming kinked due to excessive pressure being applied to the device as it was attempted to be advanced into position.Complaints of this nature will continue to be monitored for potential emerging trends.

Manufacturer Narrative

Cancellation report is being submitted due to medical affairs input received 02-apr-2024.Clinical confirms this case does not meet the criteria of a serous injury report - "the use of the graspers to retrieve the stent is not deemed ¿necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure¿.The use of the graspers is not a surgical intervention.The stent had not been fully placed into the ureter before being pulled out, there was no injury to the mucosa." fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.Device evaluation: 01 x rms-060024-r of lot c1970483 was returned to cirl opened in its original packaging.With the information provided, a physical examination and document-based investigation was conducted.Device photos and video provided show the device in packaging, it is not clear from the photos and videos where the kink is.03 attempts for additional information were made unsuccessfully.Should information be returned upon completion of the investigation, this file will be reopened and updated accordingly.Lab evaluation: the device related to this occurrence underwent a laboratory evaluation.Lab evaluation date: 21 dec 2023.Visual inspection: stent and introducer returned.Introducer has kink/compressed just after the end of the stent in the tube.Stent is fully inside introducer.Functional inspection: kink observed approximately 17.5 cm from the introducer tip.Ruler: ipe0402.Manufacturing records 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.Review historical data: a review of the manufacturing records for rms-060026-r of lot number c1970483 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 c1970483.It should be noted that the instructions for use (ifu0020) states the following: ¿improper handling of the stent prior to insertion into the ureter may harm the functionality of the stent.Bending, stretching or any other type of improper handling may deform the stent.It is important that stent is handled with care¿."with introduction catheter and sheath in proper position, remove introduction catheter to allow passage of stent".There is no evidence to suggest the user did not follow the ifu.Image review n/a.Root cause analysis: a definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As there is limited information provided, a potential root cause is difficult to ascertain.Based on the information to date, a possible root cause could be attributed to the introducer becoming kinked due to excessive pressure being applied to the device as it was attempted to be advanced into position.Confirmation of complaint complaint is confirmed based on the visual and/or functional inspection.Corrective action/ correction: complaints of this nature will continue to be monitored for potential emerging trends.Summary of investigation: complaint is confirmed based on the visual and/or functional inspection.Failure identified: introducer kinked - 01 device confirmed used.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.The device was removed successfully with graspers.A definitive root cause could not be determined as the circumstances of use cannot be replicated in the laboratory.As there is limited information provided, a potential root cause is difficult to ascertain.Based on the information to date, a possible root cause could be attributed to the introducer becoming kinked due to excessive pressure being applied to the device as it was attempted to be advanced into position.Complaints of this nature will continue to be monitored for potential emerging trends.

Event Description

Cancellation report is being submitted due to medical affairs input received 02-apr-2024.Clinical confirms this case does not meet the criteria of a serous injury report - "the use of the graspers to retrieve the stent is not deemed ¿necessitates medical or surgical intervention to preclude permanent impairment of a body function or permanent damage to a body structure¿.The use of the graspers is not a surgical intervention.The stent had not been fully placed into the ureter before being pulled out, there was no injury to the mucosa." fda mdr reporting not required: the event does not meet the criteria of an fda ¿serious injury¿ report or ¿malfunction¿ report as per fda guidelines ¿medical device reporting for manufacturers (2016)¿.No reporting malfunction precedence exists for this complaint event for this product family.No risk/ low risk of failure mode indicates no potential for serious injury if the malfunction were to recur.No adverse effect to the patient was reported as occurring.

• 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: 18366252
• MDR Text Key: 331010942
• Report Number: 3001845648-2023-00937
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 02/12/2024

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 Catalogue Number: RMS-060024-R
• Device Lot Number: C1970483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/22/2023
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/20/2023
• Supplement Dates Manufacturer Received: 11/22/2023
• Supplement Dates FDA Received: 02/23/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1