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

Model Number	M0061552220
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A visual evaluation of the returned device found that stent was broken 17 cm from the renal pigtail.The broken section 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.Based on the product analysis, it is most likely that anatomical/procedural factors were encountered during the procedure which may have limited the overall performance of the device.The failure noted was most probably caused due to the force used (torcion generated) when the stent was pulled out from the patient's body.Additionally, this failure is consistent with one caused by the suture when it is being pulled, or due to the forceps use during the stent removal.Therefore, the most probable root cause selected for the complaint is "operational context".A dhr (device history record) review was performed and no deviation was found.A labeling review was performed and no anomalies were found.
Event or Problem Description
It was reported to boston scientific corporation that a polaris¿ loop ureteral stent was implanted in the kidney during a ureteroscopy procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the coil of the stent detached inside the patient.The detached piece was successfully retrieved from the patient using forceps.The procedure was completed with another polaris¿ 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 ¿stable¿.

• Brand Name: POLARIS¿ LOOP
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7016775
• Report Number: 3005099803-2017-03245
• Device Sequence Number: 19157398
• Product Code: FAD
• UDI-Device Identifier: 08714729421023
• UDI-Public: 08714729421023
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K030503
• 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
• Report Date (Section B): 10/13/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/13/2018
• Device Model Number: M0061552220
• Device Catalogue Number: 155-222
• Device Lot Number: 17590291
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/13/2017
• Initial Report FDA Received Date: 11/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention