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

Model Number M0061603250

Device Problems Break (1069); Defective Device (2588)

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

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event was approximated to (b)(6) 2021 based on the date the manufacturer became aware of the event.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(b)(4).The returned percuflex urinary diversion stent was analyze.A visual evaluation noted that the connectors were disassembled and the grommet was deformed.Three cap connectors were received.One blue connector was received disassembled and no issues were noted on it.The grommet for the red and blue connector showed evidence of been tightened with the cap.The returned device had the distal section detached/separated.The detached section was not returned with the device.The extra blue connector was received disassembled and no problems were noted on it.A functional evaluation noted that the catheter and the two connectors cannot be correctly loaded.No other problems with the device were noted.The reported event was confirmed.The analysis of the returned device revealed that the distal end of the ureteral stent was detached/separated.Additionally, the device was out of the original pouch and the part detached was missing, evidence that the stent was manipulated out of the package.The deformed grommet shows evidence of manipulation since the cap connector was tighter that the other received in good shape.The problem found related to the detached distal section could have been generated by the user or due to the interacting of the device with other devices involved during procedure.If the device is manipulated in an improper manner it could be damaged and leaded to the issue reported and found in the device.Most likely procedural factors, such as handling of the device, the technique used by the physician, and normal procedural difficulties could have resulted in the reported problems; therefore, it is possible that factors and/or conditions related to handling of cap connectors could have affected its performance and its intended purpose, leading to the reported event.Taking into consideration the evaluation conducted at the complaint investigation site and the details of the complaint, this investigation is assigned the most probable cause of adverse event related to procedure.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.

Event Description

It was reported to boston scientific corporation that a percuflex urinary diversion ureteral stent was used during a stent replacement procedure in the urinary tract, performed on an unknown date.During preparation, when the physician attempted to attach the color code adapter to the stent, a resistance was felt and could not connect the adapter to the stent.The white rubber inside appeared to have shifted and was blocking the insertion port.The procedure was completed with a non bsc device.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.

• 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 MA 02171 ; CS 02171
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 11773423
• MDR Text Key: 248981993
• Report Number: 3005099803-2021-02045
• Device Sequence Number: 1
• Product Code: LJE
• 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: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/04/2021

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: M0061603250
• Device Catalogue Number: 160-325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/12/2021
• Initial Date FDA Received: 05/04/2021
• 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