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

Model Number	M0061603300
Medical Device Problem Codes	Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Initial reporter state: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an percuflex urinary diversion stent was used during a stent placement procedure in the ureter, performed on (b)(6) 2022.During the procedure, it was found that the guidewire could not cross and the tip of the percuflex urinary diversion stent was flattened.The procedure was successfully completed using another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be as no patient injury.
Event or Problem Description
It was reported to boston scientific corporation that an percuflex urinary diversion stent was used during a stent placement procedure in the ureter, performed on april 25, 2022.During the procedure, it was found that the guidewire could not cross and the tip of the percuflex urinary diversion stent was flattened.The procedure was successfully completed using another percuflex urinary diversion stent.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be as no patient injury.
Additional Manufacturer Narrative
Block d4: device lot number 28245814 provided but would not populate.Block e1: initial reporter state: (b)(6).Block h6: medical device code a0406 captures the reportable event of stent material deformation inside the patient.Block h10: the returned percuflex urinary diversion stent was analyzed, and a visual evaluation noted that the renal pigtail returned kinked, and a mandrel 0.039 was loaded into the device and no resistance was felt.No other issues with the device were noted.The reported event was not confirmed.According to the product analysis, the device found with the renal pigtail kinked.So according to all evidence collected, it is possible that operational factors, such as the force used when the stent is pushed up or excess of force applied during it used could cause the kinked and at the same time hinds that guide wire pass freely.Consequently, affect the performance of the device.Therefore, the most probable cause of this complaint is adverse event related to procedure since it is the most likely that the adverse event occurred during the procedure and the device had no influence on event.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 47460 ; CS 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14477362
• Report Number: 3005099803-2022-02733
• Device Sequence Number: 17433358
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/14/2022

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 Model Number: M0061603300
• Device Catalogue Number: 160-330
• 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: 04/28/2022
• Supplement Date Received by Manufacturer: 06/22/2022
• Initial Report FDA Received Date: 05/23/2022
• Supplement Report FDA Received Date: 07/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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