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

Model Number	M0061921310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris¿ ultra stent was to be implanted in an ureteroscopic lithotripsy (ursl) procedure performed in the uterine on (b)(6) 2017.According to the complainant, during preparation, the physician noted that the stent was broken into two pieces along the shaft.This device was not used in the patient.The procedure was completed with another polaris¿ ultra 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 stable.
Additional Manufacturer Narrative
A visual analysis of the returned device revealed that the stent was detached at the bladder pigtail; also the suture hole was torn.The suture itself was not returned.Based on the event description, the failure was noted during unpacking and outside of the patient, and it is possible that the way in which the device was handled and manipulated may have contributed to the failure encountered (stent detached).Also the detached section of the returned device has marks and irregularities on its surface which indicates torsion to the unit.Based on the condition of the returned unit, it was concluded that the failure found was not caused mechanically by a sharp object.Moreover, the damage found (ripped/torn) is consistent with failures caused by the suture when it is being pulled.Therefore, based on all the available information, it is most likely that the complaint was caused by the handling of the device and the most probable cause 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¿ ultra stent was to be implanted in an ureteroscopic lithotripsy (ursl) procedure performed in the uterine on (b)(6) 2017.According to the complainant, during preparation, the physician noted that the stent was broken into two pieces along the shaft.This device was not used in the patient.The procedure was completed with another polaris¿ ultra 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 stable.

• 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: 7128927
• Report Number: 3005099803-2017-03818
• Device Sequence Number: 11212177
• Product Code: FAD
• UDI-Device Identifier: 08714729124405
• UDI-Public: 08714729124405
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K010002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2017

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: M0061921310
• Device Catalogue Number: 192-131
• Device Lot Number: 0020348307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 12/06/2017
• Supplement Date Received by Manufacturer: 01/10/2018
• Initial Report FDA Received Date: 12/19/2017
• Supplement Report FDA Received Date: 02/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 60