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

Model Number	M0061603300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2019 as no event date was reported.(b)(6).(b)(4).A percuflex urinary diversion stent was returned for analysis.A visual evaluation of the returned device revealed that the pigtail section of the stent was kinked.Additionally, the shaft of the stent was detached / cut at the middle section.The most proximal section of the attached stent was not returned for analysis.The failures found (stent detached and kinked) are issues 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.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that an urinary diversion stent was used in a procedure.The event date was not reported.According to the complainant, during preparation, it was noticed that the stent was kinked at the distal tip.Another urinary diversion stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Investigation results revealed the stent shaft was detached, therefore this event has been deemed an mdr reportable event.

• 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: 9140543
• Report Number: 3005099803-2019-04837
• Device Sequence Number: 13909534
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/01/2019

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: 10/16/2021
• Device Model Number: M0061603300
• Device Catalogue Number: 160-330
• Device Lot Number: 0023255206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/10/2019
• Initial Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1