MAUDE Adverse Event Report: GYRUS ACMI, INC. SOF-CURL URETERAL STENT, 7.0FR X 26CM; STENT, URETERAL

Model Number SSC7026

Device Problems Corroded (1131); Degraded (1153); Peeled/Delaminated (1454); Device Contamination with Body Fluid (2317); Sharp Edges (4013)

Patient Problem Urinary Tract Infection (2120)

Event Type  Injury  

Event Description

It was reported to olympus that the sof-curl 7.0x24, lum ss.038x3 placed during a cystoscopy was visibly defective.Initial information stated that the device had caused some urinary tract infections (uti) and impacted the patient¿s quality of life.Upon follow up with the reporter, the information was contradictory.The reporter communicated that the patient had a complex history that included neurogenic bladder and bowel due to an automobile accident in (b)(6) 2021.Due to this, the patient lost bladder control and required self catheterization.Shortly after the accident, a non-olympus device was placed to help with urinary problems.It was stated that this procedure was ¿botched¿ and the patient had consistent issues with utis.That device was taken out on an unspecified date.The olympus device was then placed for 10 days on (b)(6) 2022 for ¿peephole problems.¿ upon removal of the device, it was noted that the end of the stent was ¿corroded.¿ the ¿plastic¿ was worn down, the end was pointy, and ¿paint¿ had peeled off.Additionally, it was covered with white ¿goo.¿ the device will not be returned as the patient kept it for litigation purposes against the implanting physician.Additional information has been requested.Olympus is reporting conservatively due to insufficient and conflicting information of the relationship of the device to the uti.

Manufacturer Narrative

The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.

Event Description

Additional information regarding the procedure indicated that the following procedures were performed: cystoscopy, left retrograde ureteropyelogram, left ureteroscopy, balloon dilation and insertion of a left ureteral stent.A questionable obstruction was noted pre-procedure.During the procedure, the patient was given intravenous antibiotics.The prostate was noted to have obstructing medial lobes in the prostate.No foreign bodies were noted in the bladder.During the retrograde ureteropyelogram, the patient was noted to have a severely tortuous dilated ureter to the level of the distal ureter and bladder.A wire was inserted to advance into the left renal collecting system.The cystoscope was removed and a semi rigid ureteroscope was inserted and advanced to the distal ureter.Some mucusal edema was noted but no foreign bodies or stones were noted.The scope was advanced to midureter, and the ureter was found to be dilated.Urine was collected and sent for culture.As the area was edematous, balloon dilatation was done of that area.The ureteral stent was then placed with the proximal curl he left renal pelvis and the distal curl in the bladder.The patient was taken to the recovery room in stable condition.A renal ultrasound post procedure revealed persistent hydronephrosis even with the sof-curl.The documentation also noted that the sof-curl was only in for 7 days, not 10 as previously reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device history record was unable to be reviewed for this device since the serial/lot number was not provided.However, olympus only releases products to market that meet all manufacturing specifications and final product release criteria.Based on the results of the investigation, after review of the photos provided, it was observed that the surface of the device was worn and had no tubular shape.Instead, the tube at this section had similar cuts to the ones made with a knife.Based on the review of the photos and the report of the nonconformance occurring 10 days after implantation of the device, it was determined that the reported issue could not be contributed to the manufacturing process.This supplemental report includes a correction to e1.Olympus will continue to monitor field performance for this device.

• Brand Name: SOF-CURL URETERAL STENT, 7.0FR X 26CM
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16527185
• MDR Text Key: 311133982
• Report Number: 3011050570-2023-00018
• Device Sequence Number: 1
• Product Code: FAD
• UDI-Device Identifier: 00821925031753
• UDI-Public: 00821925031753
• 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: Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/03/2023

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 Model Number: SSC7026
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/10/2023
• Initial Date FDA Received: 03/10/2023
• Supplement Dates Manufacturer Received: 03/13/2023; 07/18/2023
• Supplement Dates FDA Received: 04/12/2023; 08/03/2023
• 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: 53 YR
• Patient Sex: Male