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

Model Number	M0061602100
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 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.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion stent set was used during a catheter replacement procedure.The exact event date was not reported.During preparation, when the device was unpacked, a kink was discovered.It was also noted that the stent shaft was broken in half.The procedure was completed using another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block b3: date of event was approximated to (b)(6) 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.Block h10: the returned urinary diversion stent was analyzed, and a magnification and visual evaluation noted that the coil kinked, and the shaft detached.A functional test with a guidewire was performed in order to see clearer the kinked reported.No other problems with the device were noted.The reported event of stent kinked, and stent shaft break was confirmed.Taking all available information into consideration, most likely, the device meets all manufacturing specifications required and passed all the controls and inspections, no abnormalities were reported during the assembly process.It is probable that the problem of stent kinked was caused due to the interaction between the guidewire and the stent device as well, such as the handling of the device could have contributed with the complaint event reported.Also, for the reported problem of stent shaft break, based on the irregular shape of the detached tips, there is enough evidence to conclude that the device was cut.Therefore, all compiled information on this investigation determines that the most probable cause is unintended use error cause or contributed to event, since the interaction between the user and device, or sample, caused or contributed to the error.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion stent set was used during a catheter replacement procedure.The exact event date was not reported.During preparation, when the device was unpacked, a kink was discovered.It was also noted that the stent shaft was broken in half.The procedure was completed using another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT SET
• Common Device Name: 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 ; 5086834015
• MDR Report Key: 18031167
• Report Number: 3005099803-2023-05705
• Device Sequence Number: 6074070
• Product Code: LJE
• UDI-Device Identifier: 08714729297178
• UDI-Public: 08714729297178
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/19/2026
• Device Model Number: M0061602100
• Device Catalogue Number: 160-210
• Device Lot Number: 0029622303
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Supplement Date Received by Manufacturer: 12/08/2023
• Initial Report FDA Received Date: 10/30/2023
• Supplement Report FDA Received Date: 01/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/20/2022
• 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
• Patient Sex: Unknown
• Patient Race: Asian