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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 M00510870
Device Problem Tear, Rip or Hole in Device Packaging (2385)
Patient Problem No Patient Involvement (2645)
Event Date 12/01/2018
Event Type  malfunction  
Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 as no event date was reported.(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 lithotripter basket device was unpacked on an unknown date.According to the complainant, inside the fedex box, the product packaging was found to have a slit through it.There was no procedure nor patient involved in this event.
 
Manufacturer Narrative
Date of event was approximated to (b)(6) 2018 as no event date was reported.Problem code 2385 captures the reportable event of slit in the product packaging.Visual examination found that the lithotripter basket device was packaged and sealed inside its original tray.The tyvek side of the tray where the label goes placed was found to be cut.It is possible that the way the package was handled and manipulated during the processes of shipping/receiving and/or storage may have contributed to the failure encountered (package cut).The defect found is typically caused due to incorrect manipulation of the product during its transport, taking into consideration that the unit was returned totally closed/sealed and inside its original package.It is the most likely that the damage found was caused with an unknown sharp instrument since the section of the package that was found cut has its appearance without irregularities and the cut looks very clean and straight.Additionally, during its manufacturing process the product is inspected in regard to its integrity.However, there is no control in how the units are handled at the field.Therefore, the investigation conclusion code of this event is "caused traced to transport/storage", since the problem was traced to the inappropriate transport or storage of the device were detected.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 lithotripter basket device was unpacked on an unknown date.According to the complainant, inside the fedex box, the product packaging was found to have a slit through it.There was no procedure nor patient involved in 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 Key8231089
MDR Text Key132506970
Report Number3005099803-2019-00020
Device Sequence Number1
Product Code LQC
UDI-Device Identifier08714729296386
UDI-Public08714729296386
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 02/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/09/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2019
Device Model NumberM00510870
Device Catalogue Number1087
Device Lot Number0022851535
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/04/2019
Date Manufacturer Received01/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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