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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET; LITHOTRIPTOR, BILIARY MECHANICAL
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BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET; LITHOTRIPTOR, BILIARY MECHANICAL Back to Search Results
Model Number M00510880
Device Problems Break (1069); Detachment Of Device Component (1104); Device Inoperable (1663)
Patient Problem No Information (3190)
Event Date 01/08/2016
Event Type  malfunction  
Event Description
Patient scheduled for esophagogastroduodenoscopy (egd)/endoscopic ultrasound (eus)/endoscopic retrograde cholangiopancreatogram (ercp).During the ercp portion, physician attempted to extract retained common bile duct (cbd) stone using a boston scientific trapezoid wire basket, which malfunctioned: the metal tip of the basket broke off from the body of the basket whilst the device was inside the patient's cbd, which required additional interventions to be used to extract the metal foreign body trapezoid tip.
 
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Brand Name
TRAPEZOID RX WIREGUIDED RETRIEVAL BASKET
Type of Device
LITHOTRIPTOR, BILIARY MECHANICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
MDR Report Key5369318
MDR Text Key36052696
Report Number5369318
Device Sequence Number1
Product Code LQC
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
Report Date 01/08/2016,01/12/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Device Operator Physician
Device Model NumberM00510880
Other Device ID Number2.5CM
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/08/2016
Event Location Hospital
Date Report to Manufacturer01/08/2016
Initial Date Manufacturer Received Not provided
Initial Date FDA Received01/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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