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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL
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BOSTON SCIENTIFIC CORPORATION CONTOUR; STENT, URETERAL Back to Search Results
Model Number M0061802320
Device Problem Defective Device (2588)
Patient Problem No Information (3190)
Event Date 06/13/2015
Event Type  malfunction  
Event Description
Surgeon requested a ureteral stent for the patient during urological surgery.The surgeon reported the stent was defective and would not work properly and passed it back off the surgical field.A second and identical stent was opened and functioned properly for the patient.Item sent to risk management.Doctor's statement in operative report: i then attempted to place a 7-french x 24 cm double pigtail ureteral stent, but it would not pass over the guidewire, it appeared to be defected.I then removed it and used a 6 french x 24 cm double pigtail ureteral stent.After a couple of placements, i finally was able to place the proximal curl in the renal pelvis and distal curl in the bladder.
 
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Brand Name
CONTOUR
Type of Device
STENT, URETERAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key4890947
MDR Text Key6023525
Report Number4890947
Device Sequence Number1
Product Code FAD
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 06/24/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2015
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Physician
Device Model NumberM0061802320
Device Catalogue NumberM0061802320
Device Lot Number17858830
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA06/24/2015
Event Location Hospital
Date Report to Manufacturer07/06/2015
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age31 YR
Patient Weight108
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