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

Catalog Number	RMS-060024-R
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Per the doctor's post-op note: transurethral: "the bladder was examined.The indwelling cook resonance stent was seen to have a small amount of stone debris attached to it for distance of approximately 2 cm." percutaneous: "the flexible nephroscope was passed down to the proximal end of the cook resonance stent which was present in the proximal ureter.No significant debris was present upon this.Multiple attempts were made with multiple devices to engage the stent and remove it, but these were not successful.During these attempts the access sheath did pull back out of the kidney and access was reestablished by the physician and the interventional radiology team.The flexible ureteroscope was then passed into the renal pelvis and down the left ureter alongside the coil in the resident stent which was present in the upper ureter.This was passed distally where a 8 mm stone was encountered in the mid ureter attached to the stent." updated (b)(6) 2024: surgery dates: (b)(6) 2024: cystoscopy, left retrograde pyelogram, left ureteroscopy, attempted removal of left ureteral stent unsuccessful.(b)(6) 2024: cystoscopy, bilateral retrograde pyelogram, insertion of left ureteral stent, attempted removal of the left ureteral stent, extracorproal shockwave lithotripsy left rebal stone and distal left ureteral stone.(b)(6) 2024; cystoscopy holmium laser lithotripsy of bladder stone on stent, left percutaneous nephrostoureterolithotomy, antagrade ureteroscopy with laser lithotripsy ureter stone, exchange of left utereral stent.

• Brand Name: RESONANCE STENT SET
• Common Device Name: FAD STENT, URETERAL
• Manufacturer (Section D): COOK IRELAND LTD; o halloran road; limerick
• MDR Report Key: 20236450
• Report Number: 3005580113-2024-00063
• Device Sequence Number: 8162991
• Product Code: FAD
• UDI-Device Identifier: 10827002341101
• UDI-Public: (01)10827002341101(17)260427(10)C2047512
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Importer
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/17/2024
• Report Date (Section F): 09/17/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/27/2026
• Device Catalogue Number: RMS-060024-R
• Device Lot Number: C2047512
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/22/2024
• Device Age: 16 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2024
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Date Device Manufactured: 04/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 81 YR
• Patient Sex: Female
• Date Report Sent to FDA: 09/17/2024