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

Model Number	M0061602150
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/01/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation result of stent broken.A visual analysis of the returned percuflex¿ urinary diversion stent set found that stent was separated into three different sections.Specifically, it was broken along the working length close to the distal section, and the pigtail was also found detached.The evaluation revealed that the stent was broken.It is possible that when the package is still closed the defects noted may appear due to some aspect of shipping/handling/ storage of the device.However, the failure reported was found during preparation/ outside the patient.The defects encountered could have been caused due to the force applied when the catheter was being manipulated, possibly when trying to advance the stent over the wire.The defect found is consistent with one caused wire being pushed through the stent with excess force which may cause damage, deformities or device break.Additionally, during manufacturing process the units are inspected in order to avoid or to detect defects.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 set was used during a procedure performed on (b)(6) 2016.According to the complainant, the stent's pigtail detached as the surgeon went to thread it over the guide wire.The procedure was completed with another percuflex¿ urinary diversion stent set.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.This event has been deemed a reportable event based on the investigation results; stent broken.

• Brand Name: PERCUFLEX¿ URINARY DIVERSION STENT SET
• Common Device Name: CATHETER, NEPHROSTOMY
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6321220
• Report Number: 3005099803-2017-00252
• Device Sequence Number: 11020829
• Product Code: LJE
• UDI-Device Identifier: 08714729297185
• UDI-Public: (01)08714729297185(17)20170224(10)0015898227
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K830803
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/18/2017

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: 02/24/2017
• Device Model Number: M0061602150
• Device Catalogue Number: 160-215
• Device Lot Number: 0015898227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/18/2017
• Initial Report FDA Received Date: 02/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1