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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 M0061921320
Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 09/01/2020
Event Type  malfunction  
Manufacturer Narrative
Date of event: date of event was approximated to (b)(6) 2020 as no event date was reported.The complainant was unable to provide the suspect device lot number, therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was opened.Procedural information and event date were not reported.According to the complainant, during the removal of the device from the cardboard, it was found that the stent was broken.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a polaris ultra ureteral stent was opened.Procedural information and event date were not reported.According to the complainant, during the removal of the device from the cardboard, it was found that the stent was broken.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Manufacturer Narrative
Block b3: date of event: date of event was approximated to 09/01/2020 as no event date was reported.Block h6: device code 1069 captures the reportable event of stent shaft broken.Block h10: the returned polaris ultra ureteral stent was analyzed, and a visual evaluation noted that the middle section detached/separated.The shaft middle section was observed with several kinks and the suture string was returned unloaded from the device.No other issues with the device were noted.The reported event was confirmed.Based on product analysis, the stent returned with the suture string unloaded form the device and out of the original pouch; it is evidence that the stent was manipulated.Therefore, the problems found, stent shaft separated/detached and stent kinked, are issues that could have been generated by the user or due to the interaction of the device with the suture string and incorrect manipulation of the device during preparation.The most probable cause of those failures is adverse event related to procedure since it is the most likely that the adverse event occurred during the preparation and the device had no influence on event.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.H10: blocks d4 (lot number and expiration date) and h4 (device manufacture date) have been updated with additional information received on november 04, 2020.
 
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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
MDR Report Key10582292
MDR Text Key208428890
Report Number3005099803-2020-04157
Device Sequence Number1
Product Code FAD
UDI-Device Identifier08714729124429
UDI-Public08714729124429
Combination Product (y/n)N
PMA/PMN Number
K010002
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/23/2020
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 Expiration Date11/26/2020
Device Model NumberM0061921320
Device Catalogue Number192-132
Device Lot Number0021434627
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/03/2020
Initial Date Manufacturer Received 09/02/2020
Initial Date FDA Received09/24/2020
Supplement Dates Manufacturer Received11/04/2020
Supplement Dates FDA Received11/23/2020
Patient Sequence Number1
Patient Age55 YR
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