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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 Problems Break (1069); Difficult to Open or Close (2921); Material Deformation (2976); Material Split, Cut or Torn (4008)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/01/2020
Event Type  malfunction  
Manufacturer Narrative
The exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.(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 basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the side car rx tunnel was torn upon inserting the basket into the bile duct.The device was still used in capturing stones but there was difficulty closing the basket.Due to a lot of force in closing the basket, the thumb ring broke.The basket was still able to close and was removed from the patient.The photo submitted by the customer also found the side car rx tunnel was pushed back and the sheath also kinked.There were no patient complications as a result of this event.
 
Manufacturer Narrative
Block b3: the exact date of the event is unknown.The provided event date was chosen as a best estimate based on the date that the manufacturer became aware of the event.Block h6: device code a0401 captures the reportable event of thumb ring break.Device code a0406 captures the reportable event of side car push back.Block h10: visual analysis of the returned device found the thumb ring broken.There were marks, evidence that the parts were previously joined.The working length was found kinked and the sheath was found torn.The side car was found pushed back out of specification.Based on all available information, it is most likely that procedural factors encountered during its use could have affected the device's performance and integrity.The kinks on the working length are likely to happen during its use, depending on the way in which the device was manipulated, or the technique used during the procedure, like the use of the scope elevator.These kinks on the working length are the reason why the sidecar rx tunnel is pushed back from the tip.The torn sidecar rx tunnel is likely due to manipulation and got damaged by the stones, interaction with other devices, or while retrieving the guidewire too fast.As for the thumb ring break, most likely the kinks and damages on the sheath exerted enough pressure on the working length for the force to not reach the distal section, which could have resulted in the thumb ring breaking instead of the basket tip.Therefore, the most probable root cause is adverse event related to procedure.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, there is no indication that the device was not used in accordance with the ifu (instructions for use).
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.According to the complainant, during the procedure, the side car rx tunnel was torn upon inserting the basket into the bile duct.The device was still used in capturing stones but there was difficulty closing the basket.Due to a lot of force in closing the basket, the thumb ring broke.The basket was still able to close and was removed from the patient.The photo submitted by the customer also found the side car rx tunnel was pushed back and the sheath also kinked.There were no patient complications 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 Key11117660
MDR Text Key225290166
Report Number3005099803-2020-06478
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 02/18/2021
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 Date09/19/2020
Device Model NumberM00510880
Device Catalogue Number1088
Device Lot Number0024465240
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/07/2021
Initial Date Manufacturer Received 12/09/2020
Initial Date FDA Received01/05/2021
Supplement Dates Manufacturer Received01/28/2021
Supplement Dates FDA Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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