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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 M00510880
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Although the suspect device has been received for analysis, 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 a mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a biliary stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the guidewire was passed through, the trapezoid rx basket was inserted.On the endoscope screen, a green object was found attached/adhered on the tip part of the basket.The device was removed and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during a biliary stone removal procedure performed on (b)(6) 2019.According to the complainant, during the procedure, after the guidewire was passed through, the trapezoid rx basket was inserted.On the endoscope screen, a green object was found attached/adhered on the tip part of the basket.The device was removed and another trapezoid rx basket was used to complete the procedure.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Device code 2944 captures the reportable event of foreign material present in device.Visual inspection of the returned device found green residues attached/adhered in the tip of the basket.No other issues with the device were noted.Ftir analysis of the green material found that it was a 94.78% spectral match with fatty alkanolamide and 94.14% match with cochineal, a food coloring substance.These results indicate that the foreign matter is organic material and likely a food coloring substance that adhered to the device during the procedure and inside the patient.Additionally, 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.Therefore, based on all available information, the investigation concluded that the most probable root cause of the event is adverse event related to procedure.
 
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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 Key8782455
MDR Text Key150846909
Report Number3005099803-2019-03558
Device Sequence Number1
Product Code LQC
UDI-Device Identifier08714729296393
UDI-Public08714729296393
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 10/10/2019
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 Date06/18/2019
Device Model NumberM00510880
Device Catalogue Number1088
Device Lot Number0022263629
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/03/2019
Initial Date Manufacturer Received 06/17/2019
Initial Date FDA Received07/11/2019
Supplement Dates Manufacturer Received09/15/2019
Supplement Dates FDA Received10/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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