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

Model Number M0061603300

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 04/25/2022

Event Type  malfunction  

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 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 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.

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
• 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 47460 ; CS 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 14477362
• MDR Text Key: 292996622
• Report Number: 3005099803-2022-02733
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: 08714729821144
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 06/22/2022
• Supplement Dates FDA Received: 07/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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