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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 M00510860
Device Problems Separation Failure (2547); Material Split, Cut or Torn (4008)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/14/2019
Event Type  Injury  
Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
 
Event Description
Note: this report pertains to one of two trapezoid rx baskets used in the same procedure.It was reported to boston scientific corporation that two trapezoid rx lithotripter baskets were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a basket failed to crush a stone and failed to release.As pressure was applied with an alliance handle, the sheath of the basket sheared on the distal end.The same issue occurred with a second basket.The baskets were removed from the stones with a combination of dilation balloons and biopsy forceps.A stent was placed, and the procedure was aborted.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 fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
 
Event Description
Note: this report pertains to one of two trapezoid rx baskets used in the same procedure.It was reported to boston scientific corporation that two trapezoid rx lithotripter baskets were used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a basket failed to crush a stone and failed to release.As pressure was applied with an alliance handle, the sheath of the basket sheared on the distal end.The same issue occurred with a second basket.The baskets were removed from the stones with a combination of dilation balloons and biopsy forceps.A stent was placed, and the procedure was aborted.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 fine.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.
 
Manufacturer Narrative
Block d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: device code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found the handle cannula detached from the handle.The wire assembly had been pulled out (extracted) from its original position.The dimples were visible on the handle cannula and were properly located.Drag marks were present from the proximal and distal screw toward the proximal end as the cannula had been forcibly pulled out from the set screws.During evaluation, the handle label was removed exposing the set screws which were found to be present in the handle assembly.The distal and proximal screw depth was measured and found to be within specification.Additionally, the pull wire was observed kinked in different sections.The thumb ring and the finger ring were detached from the handle; however, the handle has coincident marks that indicate proper assembly during manufacturing.The basket wires were found to be deformed and the tip was intact and still attached to the basket wires assembly.Additionally, the side car tunnel was found torn and pushed back out of specification.Since the issue occurred during procedure, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use can lead to bent or deformed basket wires and pull wire kinks.Interaction with other devices could have also contributed to the bent/deformed basket.The interaction with the guidewire could have contributed to torn and pushback side car.The encountered failure is consistent with one caused when the guidewire is pulled through the sidecar tunnel while it is place in the tunnel.Additionally, handling and manipulation of the device during its use can lead to the handle cannula pulling out from the finger ring.Drag marks observed in the handle cannula indicates that a lot of force was applied to the handle to crush the stone or retract the basket resulting in the handle cannula detachment.Therefore, the most probable root cause is adverse event related to procedure.A manufacturing batch record review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a device history record (dhr) review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the 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 Key8812158
MDR Text Key151743887
Report Number3005099803-2019-03676
Device Sequence Number1
Product Code LQC
UDI-Device Identifier08714729296379
UDI-Public08714729296379
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 09/06/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM00510860
Device Catalogue Number1086
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2019
Initial Date Manufacturer Received 06/24/2019
Initial Date FDA Received07/22/2019
Supplement Dates Manufacturer Received08/14/2019
Supplement Dates FDA Received09/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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