MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) PERCUFLEX¿ URINARY DIVERSION STENT; CATHETER, NEPHROSTOMY

Model Number	M0061603300
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual analysis of the returned percuflex¿ urinary diversion stent found that the renal pigtail side of the stent was found bent/kinked.Moreover, the stent was also broken at the middle section.It is possible that the way in which the device was handled and manipulated during unpacking or preparation may have contributed to the failure encountered (stent broken).During manufacturing the units are inspected in order to avoid the failures found.Most likely, the damages found are consistent with one caused when catheter is being pulled; this may cause damage, deformities or device break.Therefore, the most probable root cause assigned to the complaint is ¿handling damage.¿ the device history record (dhr) review found that the device met all manufacturing specifications.A search of the complaint database revealed 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 stent was used during a procedure performed on (b)(6) 2017.According to the complainant, the stent was found kinked.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the stent shaft was found broken.

• Brand Name: PERCUFLEX¿ URINARY DIVERSION STENT
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6461786
• Report Number: 3005099803-2017-00900
• Device Sequence Number: 10881754
• Product Code: LJE
• UDI-Device Identifier: 08714729821144
• UDI-Public: (01)08714729821144(17)20190831(10)0020111895
• Combination Product (Y/N): N
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/09/2017

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: 08/31/2019
• Device Model Number: M0061603300
• Device Catalogue Number: 160-330
• Device Lot Number: 0020111895
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/09/2017
• Initial Report FDA Received Date: 04/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1