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

Model Number M0061603300

Device Problems Break (1069); Material Deformation (2976)

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

Event Date 02/01/2022

Event Type  malfunction  

Event 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.

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
• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13967041
• MDR Text Key: 288311111
• Report Number: 3005099803-2022-01617
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 03/08/2022
• Initial Date FDA Received: 03/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/14/2021
• 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