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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 Known Impact Or Consequence To Patient (2692)
Event Date 02/11/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used during an unknown procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a basket was used in the common bile duct and wires broke.No patient complications have been reported as a result of this event.
 
Manufacturer Narrative
Block h6: device code 1069 captures the reportable event of wires broke.Block h10: the returned trapezoid rx lithotripter basket was analyzed, and a visual evaluation found that the basket was extended and it did not have any broken wires.The working length was bent in several locations at the distal section of the device.Additionally, the handle cannula was found pulled out of the finger ring portion of the handle assembly.Both of the dimples from the screws were visible at the proximal section of the handle cannula and drag marks were present from dimples towards the proximal end as the cannula had been forcibly pulled out from the set screws.The depth of the set screws were measured and found to be within specifications.A functional evaluation was not performed due to the device condition.It is possible that anatomical or procedural factors encountered during the procedure, such as manipulation during the procedure or the device encountering too much force, could have resulted in the handle cannula separating and the working length being bent.Therefore, the most probable root cause for the failures found during analysis is adverse event related to procedure.However, the reported failure of the basket wire being broken was not confirmed during the analysis.Therefore, the root cause for the reported failure is no problem detected.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.Block h11: correction: d4 (model number), d10 (device avail for evaluation?).
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used during an unknown procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a basket was used in the common bile duct and wires broke.No patient complications have been 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 Key9805722
MDR Text Key190833801
Report Number3005099803-2020-00607
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,health
Type of Report Initial,Followup
Report Date 04/16/2020
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 Date10/15/2020
Device Model NumberM00510890
Device Catalogue Number1089
Device Lot Number0024604617
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/21/2020
Initial Date Manufacturer Received 02/11/2020
Initial Date FDA Received03/09/2020
Supplement Dates Manufacturer Received03/23/2020
Supplement Dates FDA Received04/16/2020
Patient Sequence Number1
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