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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS¿ LOOP; STENT, URETERAL
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BOSTON SCIENTIFIC - COSTA RICA (COYOL) POLARIS¿ LOOP; STENT, URETERAL Back to Search Results
Model Number M0061552210
Device Problem Material Deformation (2976)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/18/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Exact patient age unknown, but reported to be over 18 years of age.Reported event of "stent would not curl." 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 Description
It was reported to boston scientific corporation that a polaris¿ loop ureteral stent was used during a left flexible ureteroscopy procedure performed in the kidney of a patient on (b)(6) 2016.According to the complainant, during the procedure, the stent did not coil in the kidney despite several attempts.The device was pulled out and the procedure was completed with a different 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 stable.
 
Manufacturer Narrative
A visual analysis found no anomalies or damage to the device.Dimensional inspection of the stent's working length was performed and found that it is within specification.During functional analysis, a 0.038 mandrel was inserted and it passed properly without resistance; both coils formed without any problem when the guidewire was removed.The complaint that the stent did not curl was not confirmed.The device showed no evidence of either the alleged issue or any defect which could have contributed to the event.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
 
Event Description
It was reported to boston scientific corporation that a polaris¿ loop ureteral stent was used during a left flexible ureteroscopy procedure performed in the kidney of a patient on (b)(6) 2016.According to the complainant, during the procedure, the stent did not coil in the kidney despite several attempts.The device was pulled out and the procedure was completed with a different 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 stable.
 
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Brand Name
POLARIS¿ LOOP
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 Key5498902
MDR Text Key40303504
Report Number3005099803-2016-00536
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeSG
PMA/PMN Number
K030503
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/18/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date07/16/2018
Device Model NumberM0061552210
Device Catalogue Number155-221
Device Lot Number18208762
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/29/2016
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/20/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/29/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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