MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX URINARY DIVERSION STENT SET; CATHETER, NEPHROSTOMY

Model Number M0061602100

Device Problem Break (1069)

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

Event Date 11/01/2023

Event Type  malfunction  

Event Description

Note: this report is one of two complaints that pertain to the same event (mfr.Report mfr.Report # 2124215-2023-70020).It was reported to boston scientific corporation that a percuflex urinary diversion stent set was used during a flexible ureteroscopy procedure to treat kidney stones in the urethra, bladder and ureter.The exact event date was not reported.During the procedure, when the device was inserted, the stent was found broken.The procedure was successfully completed with non-boston scientific device.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block b3: date of event was approximated to november 1, 2023, based on the date the manufacturer became aware of the event.Block h6: imdrf device code a0401 captures the reportable event of stent shaft broken.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT SET
• Type of Device: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: farshad fahimi ; 4100 hamline avenue north; building c; saint paul, MN 55112
• MDR Report Key: 18343857
• MDR Text Key: 330715176
• Report Number: 2124215-2023-70013
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: 08714729297178
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K830803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0061602100
• Device Catalogue Number: 160-210
• Device Lot Number: 0030931336
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/22/2023
• Initial Date FDA Received: 12/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2023
• 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