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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 11/27/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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 lithotripsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the wires of the basket broke but still attached to the device.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 1069 captures the reportable event of basket wire break.Block h10: visual inspection of the returned device found the device is free of obvious kinks and bends.The handle cannula and tip were properly placed on the device.Additionally, the handle was actuated, and the basket was able to open and close without any issues.It was determined that the device did not have any broken wire.Based on all available information, the investigation concluded that the device did not have any visual damage/defect and worked as intended.There was no evidence of either the alleged issue or any defect that could have contributed to the reported event.Therefore, the most probable cause is no problem detected.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.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the wires of the basket broke but still attached to the device.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.
 
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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 Key9489045
MDR Text Key189841107
Report Number3005099803-2019-06165
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 02/04/2020
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 Date08/28/2020
Device Model NumberM00510890
Device Catalogue Number1089
Device Lot Number0024347107
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Initial Date Manufacturer Received 12/02/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received01/12/2020
Supplement Dates FDA Received02/04/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age54 YR
Patient Weight56
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