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

Catalog Number UNKNOWN

Device Problem Off-Label Use (1494)

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

Event Date 06/06/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Hsu, 2021, rms and risk factors for primary failure of metallic ureteral stents: experience from a tertiary center in our hospital, the retrograde method of stent insertion is performed under general anesthesia by urologists.Initially, an introduction set similar to an 8f/10f dilator is passed over a guidewire into the renal pelvis.The wire and inner catheter are removed, and the resonance stent is passed through the 10f introducer sheath.The inner catheter is then used to push the stent proximally until the pigtail is placed in the renal pelvis.Finally, the 10f sheath is retracted with the inner catheter held in place until the distal pigtail is deployed in the bladder.The whole procedure is performed under fluoros-copy.A total of 124 stents were inserted into 96 patients because there were 28 patients having bilateral stents.21 cases off label rms being placed for intrinsic compression - urinary tract cancer i.E., intraluminal.

Manufacturer Narrative

Device evaluation: the resonance stent set devices of unknown lot # were not available for evaluation, therefore a document based investigation will be carried out.As the lot # of the resonance stent set device is unknown it is not possible to carry out a review of the manufacturing records.However, prior to distribution all resonance stent set 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.As per instructions for use (ifu0020-18): ¿used for temporary stenting of the ureter in adult patients with extrinsic ureteral obstruction.Intended for one time use.¿ there is evidence to suggest the user did not follow the instructions for use which accompany this device.Root cause review: a definitive root cause can be attributed to off label use.When the device is used outside of its validated state it is not possible to definitively state how the device will perform.The use of the resonance stents in ureters with intrinsic causes of compression, urinary tract cancer i.E., intraluminal, is outside of the intended use set out in the ifu.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial report, no adverse effects reported as occurring.Complaints of this nature will continue to be monitored for 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: 12717844
• MDR Text Key: 284298705
• Report Number: 3001845648-2021-00758
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K063742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue 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: 06/06/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/29/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 12/09/2021
• 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 Age: 60 YR
• Patient Sex: Female
• Patient Weight: 55 KG