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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 Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/21/2018
Event Type  malfunction  
Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(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 lithotripter basket was used in the bile duct during a lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the handle broke when attempting to performed lithotripsy.A soehendra lithotripter was then used in an attempt to remove the stone from the basket but failed.Finally, contrast was injected into the bile duct and the stone floated out from the basket.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
A2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.H6: problem code 1069 captures the reportable event of handle breaks.H10: the trapezoid basket was received cut.The cut ends of the pull wire was inspected under magnification and revealed marks that indicate a sharp tool was used to cut the device.Additionally, the handle was found not broken.However, the handle cannula was found to have been pulled out of the finger ring portion of the handle assembly and was separated from the handle since the device was cut.The dimples were visible on the handle cannula.Drag marks were present from the proximal and distal screw toward the proximal end of the cannula as the cannula has been forcibly pulled out from the set screws.Also the working length was kinked in several locations.It is most likely that during procedure the device could have been excessively manipulated by the user, or affected by the interaction with the scope or with other devices.The attempts performed to crush the stones, actuating the device or the force applied to the device during its use could have affected its integrity.The damages (working length kinked and handle cannula pulled out of the finger ring) are issues consistent with ones caused when excess of force was applied to the product during its handling; other factors like patient anatomy can also affect the functionality of the product.Therefore, the most probable cause is "adverse event related to patient condition".A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during a lithotripsy procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the handle broke when attempting to performed lithotripsy.A soehendra lithotripter was then used in an attempt to remove the stone from the basket but failed.Finally, contrast was injected into the bile duct and the stone floated out from the basket.There were no patient complications reported as a result of this event.
 
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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 Key8161274
MDR Text Key130320270
Report Number3005099803-2018-61948
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 02/06/2019
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 Date06/06/2019
Device Model NumberM00510890
Device Catalogue Number1089
Device Lot Number0022213552
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2018
Initial Date Manufacturer Received 11/21/2018
Initial Date FDA Received12/13/2018
Supplement Dates Manufacturer Received01/10/2019
Supplement Dates FDA Received02/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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