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

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Urinary Frequency (2275)

Event Date 04/07/2021

Event Type  Injury  

Manufacturer Narrative

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

Event Description

(b)(6), 2021, the resonance and the allium ureteral stents in the treatment of non-malignant refractory ureterostenosis.18 patients underwent the procedure using a resonance stent.Intraoperative placement of ureteral stents was usually under fluoroscopic guidance.For resonance stents, 24 cm ones were chosen for patients shorter than 165 cm, 26 cm for patients between 165 and 175 cm, and 28 cm for patients taller than 175 cm.Resonance stents were replaced yearly.7 patients experienced moderate to severe overactive bladder.Moderate to severe oab happened frequently in the resonance group but not the allium group.Some patients even requested to remove the resonance stent due to disturbing oab.Those patients who had the resonance stent withdrawn and replaced by the allium stent were also satisfied with the relief of irritable symptoms.Mean age 55.7 (rounded upto 56 years).12 male and 6 female patients.

Event Description

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

Manufacturer Narrative

Device evaluation: the resonance stent set device of unknown lot # was 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 rms-060020-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.It should be noted that the instructions for use (ifu0020-18) states the following: "potential adverse events associated with indwelling ureteral stents include: urinary symptoms (frequency, urgency, incontinence, dysuria, hematuria)." 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 could not be determined from the available information.A possible root cause can be attributed to a procedural related effect as the ifu which accompanies this device lists urinary symptoms (frequency, urgency, incontinence, dysuria, hematuria) as a known complication associated with the use of the device.Summary: complaint is confirmed as the failure was verified in the laboratory.According to the initial report, the patient suffered no other adverse events.Complaints of this nature will continue to be monitored for 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: aisling hassett ; o halloran road; national technology park; limerick
• MDR Report Key: 12714352
• MDR Text Key: 281915603
• Report Number: 3001845648-2021-00768
• 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: Literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/09/2021

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/07/2021
• Event Location: Hospital
• Initial Date Manufacturer Received: 09/30/2021
• Initial Date FDA Received: 10/28/2021
• Supplement Dates Manufacturer Received: 09/30/2021
• Supplement Dates FDA Received: 12/06/2021
• 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 Outcome(s): Other
• Patient Age: 56 YR
• Patient Sex: Male