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

Model Number	M0061603300
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion ureteral stent was used during a ureteral stenting procedure in the renal pelvis and ureter.The procedure date is unknown.During the procedure, it was noticed that the renal side pigtail was kinked.Another urinary diversion stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent shaft broken.Please see block for full investigation details.
Additional Manufacturer Narrative
Event date: the exact date of the event is unknown.The provided event date, on (b)(6) 2022, was chosen as a best estimate based on the date that the manufacturer became aware of the event, on (b)(4) 2022.(b)(4).The returned urinary diversion ureteral stent was analyzed, and a visual evaluation noted that the renal pigtail was kinked, and a mandrel 0.035" was loaded into the device and no resistance was felt.It is important mention that the device did not returned complete only a portion the shaft returned.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, the device found with the renal pigtail kinked, the working length detached and only a portion returned.It is possible that operational factors, such as the force used when the stent is pushed up with the pusher over the guidewire or when the stent was used, excess of force applied during it used could cause the kinked.According to the evidence, it is possible that operational factors, interaction of the device with other device, manipulation or excess of force applied during it use, could have caused the detached observed.Consequently, affect the performance of the device.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13967041
• Report Number: 3005099803-2022-01617
• Device Sequence Number: 11806260
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: 08714729821144
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2022

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: 05/13/2024
• Device Model Number: M0061603300
• Device Catalogue Number: 160-330
• Device Lot Number: 0028078061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 03/31/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2021
• 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