MAUDE Adverse Event Report: GYRUS ACMI INC, SOF-CURL URETERAL STENT, 6.0FR X 26CM

Model Number SSC6026

Device Problem Detachment Of Device Component (1104)

Patient Problem Patient Problem/Medical Problem (2688)

Event Date 11/09/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The exact cause of the patient's outcome cannot be conclusively determined at this time.The instruction warns users: "patients or their representatives should be informed of the possible complications associated with the use of this product.Gyrus acmi requests physicians notify the company of complications which may occur with the use of this indwelling device.Complications may include but are not limited to: risks associated with the medication, procedure, and the patient's degree of tolerance to the procedure and/or device; proximal or distal migration, possibly necessitating medical or surgical intervention to reposition or remove the stent; encrustation and/or stone formation; compromised urine flow due to stent blockage or ureteral occlusion; urinary tract infection; leakage of urine; perforation of the kidney, renal pelvis, ureter, or bladder; stent breakage, possibly necessitating endoscopic or surgical removal of the device.".

Event Description

Olympus was informed that the stent became trapped in the patient's utero after undergoing a right ureteroscopy procedure.It was reported that the patient was discharged home and instructed to pull the string attached to the stent; however, the string detached and the stent remained in the patient's utero.The patient returned to the user facility and underwent a cystoscopic procedure to remove the stent.There was no long term injury reported and the patient is doing well.No further information was provided.

• Brand Name: SOF-CURL URETERAL STENT, 6.0FR X 26CM
• Type of Device: URETERAL STENT
• Manufacturer (Section D): GYRUS ACMI INC,; 136 turnpike road; southborough MA 01882 2104
• Manufacturer Contact: donny shapiro ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5268844
• MDR Text Key: 32737797
• Report Number: 2951238-2015-00572
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K930733
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SSC6026
• Device Catalogue Number: SSC6026
• Device Lot Number: MGVD640
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2015
• 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