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

Model Number	M006192132120
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device component code relates to device problem code for the reported event of stent broken.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 used in the kidney for a stone removal procedure.According to the complainant, during preparation, it was noted that the stent was broken into two pieces.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 good.
Additional Manufacturer Narrative
A polaris ultra stent was received for analysis.A visual evaluation of the returned device found that the stent was damaged at the middle section.The stent was found broken, and the broken section is located in the sideport hole.No other anomalies or damages were noted.The complaint of the stent being broken in half was confirmed.The evaluation concluded that during preparation and outside the patient, the defect noted could have been caused by the user due to excessive manipulation and interaction of the stent with suture.This type of failure is consistent with one caused when a device is pulled strongly and/or was submitted to an excess of force; excess of force may cause damage, deformities or device break.Therefore, the most probable root cause of this complaint is "handling damage".A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database revealed that no other 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 used in the kidney for a stone removal procedure.According to the complainant, during preparation, it was noted that the stent was broken into two pieces.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 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: 7665203
• Report Number: 3005099803-2018-02109
• Device Sequence Number: 13893135
• Product Code: FAD
• UDI-Device Identifier: 08714729766483
• UDI-Public: 08714729766483
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

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: 09/30/2020
• Device Model Number: M006192132120
• Device Catalogue Number: 192-132-12
• Device Lot Number: 21785968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/12/2018
• Initial Report FDA Received Date: 07/05/2018
• Supplement Report FDA Received Date: 08/01/2018
• Patient Sequence Number: 1