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

Model Number M0061921320

Device Problem Device Packaging Compromised (2916)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.According to the complainant, the suspect device has been retained and is not available for return.If any further relevant information is received, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a polaris ultra stent was used in the ureter during a cystoscopy stent exchange procedure performed in the ureter on (b)(6) 2015.According to the complainant, when they pulled out the device from the shelf, they noticed that the packaging was ripped and the interior part of the package was exposed.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 fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: POLARIS¿ ULTRA
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer (Section G): BOSTON SCIENTIFIC - COSTA RICA (COYOL); 2546 first street; propark free zone; alajuela ; CS
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 5324169
• MDR Text Key: 34274118
• Report Number: 3005099803-2015-03752
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K010002
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2015

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
• Device Operator: Physician
• Device Model Number: M0061921320
• Device Catalogue Number: 192-132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1