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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION FLEXIMA¿; STENT, URETERAL
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BOSTON SCIENTIFIC CORPORATION FLEXIMA¿; STENT, URETERAL Back to Search Results
Model Number M001274030
Device Problem Activation, Positioning or Separation Problem (2906)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/26/2016
Event Type  malfunction  
Event Description
During the placement of the stent in the left kidney, the device was found to have failed, it could not be deployed properly due to the pigtail straightener and positioning suture.After several minutes of manipulation by the attending the stent was removed and replaced with another.The stent in the right kidney was successfully placed.
 
Manufacturer Narrative
Unique device identifier (udi): for type of device: stent, ureteral.
 
Event Description
During the placement of the stent in the left kidney, the device was found to have failed, it could not be deployed properly due to the pigtail straightener and positioning suture.After several minutes of manipulation by the attending the stent was removed and replaced with another.The stent in the right kidney was successfully placed.
 
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Brand Name
FLEXIMA¿
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough, MA 01752
MDR Report Key5913317
MDR Text Key53446421
Report Number5913317
Device Sequence Number1
Product Code FAD
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/28/2016
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 Expiration Date01/18/2019
Device Model NumberM001274030
Device Catalogue NumberM001274030
Device Lot Number18813881
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA08/28/2016
Device Age1 DY
Event Location Hospital
Date Report to Manufacturer08/28/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received08/30/2016
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received08/17/2017
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Age37 YR
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