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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION POLARIS ULTRA; STENT, URETERAL
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BOSTON SCIENTIFIC CORPORATION POLARIS ULTRA; STENT, URETERAL Back to Search Results
Model Number M0061921330
Device Problems Deformation Due to Compressive Stress (2889); Difficult to Advance (2920); Positioning Problem (3009)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/01/2022
Event Type  malfunction  
Event Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a retrograde intrarenal surgery procedure, performed on (b)(6) 2022.During the procedure and inside the patient, the physician found that the device was stuck and there was difficulty in advancing through the anatomy.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Investigation results revealed the stent coil was buckled/accordion and deformed, therefore this event has been deemed an mdr reportable event.
 
Manufacturer Narrative
(b)(4).The returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was buckled accordion.The device has a guidewire inside.In microscope magnification, it was observed that through the holes of the stent the guide wire is buckled/accordion, and side port holes are stretched and device has a drag mark in the blunt.Functional inspection could not be performed due to inside of the device is with a guide wire stuck.The suture string, straightener and positioner was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it was found that the device has the bladder coil buckled/accordion and the device has inside stuck a guide wire.Also, during magnification, it was found that the side port holes were stretched and caught a drag mark on the device.According to the evidence, it is possible that operational factors, such as interacting of the device with positioner, interaction with another device, such as the guide wire, which was buckled/accordion inside the device could have contributed to bladder coil buckled/accordion.Regarding the stretched and drag marks, it is possible that manipulation or excess of force applied during its use, could have caused side port holes.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Manufacturer Narrative
Block h6: medical device problem code a040601 captures the reportable investigation result of stent coil buckled/accordion inside the patient.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the bladder coil was buckled accordion.The device has a guidewire inside.In microscope magnification, it was observed that through the holes of the stent the guide wire is buckled/accordion, and side port holes are stretched and device has a drag mark in the blunt.Functional inspection could not be performed due to inside of the device is with a guide wire stuck.The suture string, straightener and positioner was not returned for analysis.No other issues with the device were noted.The reported event was confirmed.According to the product analysis, it was found that the device has the bladder coil buckled/accordion and the device has inside stuck a guide wire.Also, during magnification, it was found that the side port holes were stretched and caught a drag mark on the device.According to the evidence, it is possible that operational factors, such as interacting of the device with positioner, interaction with another device, such as the guide wire, which was buckled/accordion inside the device could have contributed to bladder coil buckled/accordion.Regarding the stretched and drag marks, it is possible that manipulation or excess of force applied during its use, could have caused side port holes.Therefore, adverse event related to procedure is selected as the most probable root cause for the complaint.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
 
Event Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was used during a retrograde intrarenal surgery procedure, performed on (b)(6) 2022.During the procedure and inside the patient, the physician found that the device was stuck and there was difficulty in advancing through the anatomy.Another polaris ultra ureteral stent was opened and successfully completed the procedure.There were no patient complications reported as a result of this event.Investigation results revealed the stent coil was buckled/accordion and deformed, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.
 
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Brand Name
POLARIS ULTRA
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
2546 calle primera
alajuela
CS  
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key14780833
MDR Text Key302659574
Report Number3005099803-2022-03352
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729124443
UDI-Public08714729124443
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K010002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/23/2022
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 Health Professional
Device Model NumberM0061921330
Device Catalogue Number192-133
Device Lot Number0028287350
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/05/2022
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 05/31/2022
Initial Date FDA Received06/22/2022
Supplement Dates Manufacturer Received11/01/2022
Supplement Dates FDA Received11/23/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/28/2021
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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