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

Model Number	M006192133090
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
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 used in the ureter during a ureteral stent placement procedure performed on (b)(6) 2017.According to the complainant, during unpacking, it was noted that the stent was separated into two from the center.The procedure was completed with of the same device.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.
Additional Manufacturer Narrative
A visual analysis of the returned device found that the stent was found damaged (broken) at its middle section.Based on the event description analysis, 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 broken).The defect found is consistent with one caused due to some handling aspect, possibly when the device was being pulled out of the tray.The broken section of the returned device has marks and irregularities on its surface which indicates torsion or excess of force applied to the product; excess of force may cause damage, deformities or device break.Moreover, according to the condition of the returned unit, it was concluded that the failure found was not caused mechanically by a sharp object.In 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.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 used in the ureter during a ureteral stent placement procedure performed on (b)(6) 2017.According to the complainant, during unpacking, it was noted that the stent was separated into two from the center.The procedure was completed with of the same device.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.

• 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: 7030418
• Report Number: 3005099803-2017-03398
• Device Sequence Number: 13736275
• Product Code: FAD
• UDI-Device Identifier: 08714729124450
• UDI-Public: 08714729124450
• 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,Followup
• Report Date (Section B): 10/24/2017

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: 04/30/2020
• Device Model Number: M006192133090
• Device Catalogue Number: 192-133-09
• Device Lot Number: 20998419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Initial Date Received by Manufacturer: 10/24/2017
• Supplement Date Received by Manufacturer: 11/20/2017
• Initial Report FDA Received Date: 11/14/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1