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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL
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BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL Back to Search Results
Model Number M00510890
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/13/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a choledocholithotomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the handle cannula detached.The device was withdrawn and the procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a choledocholithotomy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the handle cannula detached.The device was withdrawn and the procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
 
Manufacturer Narrative
Block h6: problem code 2907 captures the reportable event of handle cannula detached.Block h10: visual inspection of the returned device found the handle cannula was pulled out of the finger ring portion of the handle assembly.Both dimples from the screws were visible at proximal section of the handle cannula and drag marks were present from dimples towards the proximal end, as the handle cannula had been forcibly pulled out from the set screws.The distal screw and proximal screw depth were measured, and both were found within specification.Based on all available information, the investigation concluded that procedural and anatomical factors encountered during the procedure likely affected the device's performance and integrity.Handling and manipulation of the device can lead the handle cannula pulling out from the finger ring.The drag marks in the handle cannula indicates that excessive force was applied to the handle to crush the stone resulting in handle cannula detachment.Therefore, the most probable root cause is adverse event related to procedure.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
 
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Brand Name
TRAPEZOID RX
Type of Device
LITHOTRIPTOR, BILIARY MECHANICAL
Manufacturer (Section D)
BOSTON SCIENTIFIC CORPORATION
300 boston scientific way
marlborough MA 01752
MDR Report Key9437470
MDR Text Key189767485
Report Number3005099803-2019-05982
Device Sequence Number1
Product Code LQC
UDI-Device Identifier08714729296409
UDI-Public08714729296409
Combination Product (y/n)N
PMA/PMN Number
K040447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 02/18/2020
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 Date04/02/2020
Device Model NumberM00510890
Device Catalogue Number1089
Device Lot Number0023588255
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/05/2019
Initial Date Manufacturer Received 11/13/2019
Initial Date FDA Received12/09/2019
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received02/18/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age87 YR
Patient Weight48
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