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

Model Number	M0061603250
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2020 based on the date the manufacturer became aware of the event.Initial reporter state: (b)(6).(b)(4).The returned percuflex urinary diversion ureteral stent was analyzed, and a visual evaluation noted that the shaft of the stent was detached.The most proximal section of the stent and the catheter connector were not returned and they could not be tested.A functional evaluation noted that a mandrel 0.038" was inserted through the stent and no resistance was met during its advancing.No other issues with the device were noted.The reported complaint was not confirmed.The failure found (shaft stent detached) is an issue that could have been generated by the user or due to the interacting of the device with the other devices.Therefore, adverse event related to procedure, is selected as the most probable root cause for the complaint since it is 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.A search of the complaint database confirmed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a percuflex urinary diversion ureteral stent was used during an unknown procedure on an unknown date.According to the complainant, during the procedure, the guidewire got stuck at the tip side of the catheter and was unable to cross.Another percuflex urinary diversion ureteral 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 results; stent shaft break.

• Brand Name: PERCUFLEX URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9837304
• Report Number: 3005099803-2020-00935
• Device Sequence Number: 1212856
• Product Code: LJE
• UDI-Device Identifier: 08714729821137
• UDI-Public: 08714729821137
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/16/2020

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: 09/03/2022
• Device Model Number: M0061603250
• Device Catalogue Number: 160-325
• Device Lot Number: 0024785293
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/21/2020
• Initial Report FDA Received Date: 03/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1