MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) MODIFICATION TO CONTOUR POLARIS URETERAL STENT; STENT, URETERAL

Model Number	UNK323
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.It was reported the device was not used past its expiry.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a polaris loop was used for a stent replacement procedure on an unknown date.According to the complainant, several weeks post stent placement, the polaris loop stent had migrated.It had slid out of the kidney and went too far into the ureter and was removed entirely with the use of forceps.The patient had to have a new stent implanted.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's condition at the conclusion of the procedure was reported to be "stable".
Event or Problem Description
It was reported to boston scientific corporation that a polaris¿ loop was used for a stent replacement procedure on an unknown date.According to the complainant, several weeks post stent placement, the polaris¿ loop stent had migrated.It had slid out of the kidney and went too far into the ureter and was removed entirely with the use of forceps.The patient had to have a new stent implanted.The procedure was completed with another of the same device.There were no patient complications as a result of this event, and the patient's condition at the conclusion of the procedure was reported to be "stable".

• Brand Name: MODIFICATION TO CONTOUR POLARIS URETERAL STENT
• Common Device Name: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• MDR Report Key: 7047101
• Report Number: 3005099803-2017-03495
• Device Sequence Number: 13895506
• Product Code: FAD
• UDI-Device Identifier: 08714729765349
• UDI-Public: 08714729765349
• Combination Product (Y/N): N
• PMA/510(K) Number: K030503
• 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): 11/02/2017

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 Model Number: UNK323
• Device Catalogue Number: 155-211
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 04/07/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 04/30/2018
• 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