MAUDE Adverse Event Report: GYRUS ACMI, INC. SOF-CURL URETERAL STENT 6.0X24; POLYMERIC URETERAL STENT

Model Number 5626024

Device Problems Detachment of Device or Device Component (2907); Migration (4003)

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

Event Type  Injury  

Manufacturer Narrative

The suspect device referenced in this report has not been returned to olympus.Additional information is being requested.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or if additional information is received.

Event Description

The customer reported that the sof-curl ureteral stent 6.0x24 could not be found at its intended place as confirmed through x-ray and that the curls were in the renal pelvis.A cystoscope was used to investigate, and the rest of the stent was found in the bladder.It was noted that the stent had detached between when it was initially placed on 10/11/23 until 11/01/23 when it was discovered via x-ray.There was no further harm or user injury reported due to the event.

• Brand Name: SOF-CURL URETERAL STENT 6.0X24
• Type of Device: POLYMERIC URETERAL STENT
• Manufacturer (Section D): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer (Section G): GYRUS ACMI, INC.; 800 west park drive; westborough MA 01581
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18186991
• MDR Text Key: 328735768
• Report Number: 3003790304-2023-00434
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925005631
• UDI-Public: 00821925005631
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K930733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 5626024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/09/2024
• 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): Required Intervention