MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS¿ ULTRA; STENT, URETERAL

Model Number	M006192133180
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/30/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found that the stent was broken at the middle section.No other anomalies or damages were noted.Based on the event description, the issue was identified during preparation and outside the patient.It is possible that the way in which the device was handled and manipulated may have contributed to the failure of stent broken encountered.The defect found is consistent with one caused when the device is being pulled with excess of force, as this may cause damage, deformities, or device break.During the manufacturing process the units are inspected in order to avoid or detect the failure found, however, there is no control in how devices are handled in the field.Most likely the stent was broken due to some handling aspect of the device possibly during preparation or storing.Therefore, the most probable root cause is ¿handling damage¿.A review of the device history record (dhr) confirms that the accepted 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 polaris ultra ureteral stent was going to be used in a stent placement procedure performed on (b)(6) 2017.According to the complainant, during preparation, the stent was broken at the middle section when removed from the strainer.The procedure was completed with another polaris ultra ureteral stent.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental mdr will be submitted.

• Brand Name: POLARIS¿ ULTRA
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 6521288
• Report Number: 3005099803-2017-01203
• Device Sequence Number: 340120
• Product Code: FAD
• UDI-Device Identifier: 08714729777106
• UDI-Public: (01)08714729777106(17)20191031(10)20203087
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/31/2017

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: 10/31/2019
• Device Model Number: M006192133180
• Device Catalogue Number: 192-133-18
• Device Lot Number: 20203087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/31/2017
• Initial Report FDA Received Date: 04/25/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1