MAUDE Adverse Event Report: BOSTON SCIENTIFIC - MARLBOROUGH POLARIS¿ ULTRA; STENT, URETERAL

Model Number	M006193132090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual analysis of the returned device found that the shaft was broken at 7.5 cm from the bladder pigtail.Event details stated that the event occurred during preparation, and outside of the patient.The section of the stent that was broken was inspected under magnification, and no smooth surfaces were noticed over the fracture zone, which indicates that the stent was not broken due to mechanical cut.In addition, evidence of excessive force and torsion was noted on the broken section, so it is the most likely that the complaint was caused by handling of the device or portion of the device without direct patient contact either during unpacking, or preparation.Therefore, the most probable root cause of this complaint is handling damage.A review of the device history record (dhr) was performed and no anomalies were noted.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 polaris¿ loop ureteral stent was used in the ureter during a stenting procedure performed on (b)(6) 2017.According to the complainant, during preparation, it was noted that stent was detached.The procedure was completed with another percuflex¿ loop ureteral stent.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 good.This event has been deemed a reportable event based on the investigation results; stent broken.

• Brand Name: POLARIS¿ ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - MARLBOROUGH; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 7019848
• Report Number: 3005099803-2017-03272
• Device Sequence Number: 1184318
• Product Code: FAD
• UDI-Device Identifier: 08714729762911
• UDI-Public: 08714729762911
• Combination Product (Y/N): N
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/20/2017

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: 02/29/2020
• Device Model Number: M006193132090
• Device Catalogue Number: 193-132-09
• Device Lot Number: 0020801200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/20/2017
• Initial Report FDA Received Date: 11/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1