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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 Problems Use of Device Problem (1670); Separation Failure (2547); Deformation Due to Compressive Stress (2889); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/30/2023
Event Type  Injury  
Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of basket failure to crush stones.Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf impact code f2301 captures the plastic stent implanted.Imdrf impact code f2202 captures the another ercp planned.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the trapezoid rx captured a biliary stone.The stone could not be removed as the papilla was not big enough after sphincterotomy.Additionally, the stone was entrapped inside the basket, so it was not possible to remove the basket.An alliance handle was used to attempt to crush the entrapped stone and detach the tip of the basket.However, the metal sheath got compressed, and they could no longer remove the basket.Therefore, the metal sheath was removed by cutting the handle and pulling the single wire of the metal sheath.Once the metal sheath was removed, the stone was successfully removed from the basket and the basket was removed from the patient.A plastic stent was inserted and another ercp was planned.There were no patient complications reported as a result of this event.
 
Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of basket failure to crush stones.Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf impact code f2301 captures the plastic stent implanted.Imdrf impact code f2202 captures the another ercp planned.Block h10: the returned trapezoid rx was analyzed, and a visual inspection observed that the coil, pull wire, and the sheath were detached.Also, the pull wire and basket wire were kinked.The cannula was not returned for analysis, suggesting that it was detached.Additionally, the sheath was stretched.The picture attached showed that the coil, the pull wire and the sheath were detached.Also, the pull wire and the basket wire were kinked.The reported event that the tip failed to separate, and sheath buckled material was confirmed.Based on all available information, the parts of the device were damaged in order to release the stone trapped inside the basket.The basket wires bent possibly as a result of the force applied to crush the stone.The tip could have failed to separate if the pull wire was already damaged by the force it was stressed to do when trying to crush the stone.However, this can't be seen during the product analysis.The bent and detached pull wire could be the result of the physician trying to remove the device, or the force applied during the procedure.The buckled sheath could be a result of trying to get the device out of the patient since the procedure couldn't be completed and the tip didn't separate from the device.The handle cannula didn't return for analysis, suggesting that it was detached, possibly when the device was being extracted from the patient.Therefore, the most probable root cause of tip failed to separate, coil detached, sheath detached, pull wire bent and detached, basket wire kinked, handle cannula detached, and sheath stretched is adverse event related to procedure.Basket failure to crush stone will be addressed as no problem detected since this failure can't be seen during the product analysis.The impact codes "additional device required" and "endoscopic procedure" were added as no problem detected since both codes could have only been seen during the procedure.Also, it was noticed that the device was used after the expiration date, according to the product details for the batch '30421566' the device was manufactured on 10/26/2022 and the use before date/expiration was 10/26/2023 and the procedure date was the (b)(6) 2023.This failure was addressed as shelf life/ expiration date exceeded.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.However, the device was used past expiration date.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During the procedure, the trapezoid rx captured a biliary stone.The stone could not be removed as the papilla was not big enough after sphincterotomy.Additionally, the stone was entrapped inside the basket, so it was not possible to remove the basket.An alliance handle was used to attempt to crush the entrapped stone and detach the tip of the basket.However, the metal sheath got compressed, and they could no longer remove the basket.Therefore, the metal sheath was removed by cutting the handle and pulling the single wire of the metal sheath.Once the metal sheath was removed, the stone was successfully removed from the basket and the basket was removed from the patient.A plastic stent was inserted and another ercp was planned.There were no patient complications 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
Manufacturer (Section G)
BOSTON SCIENTIFIC CORPORATION
780 brookside drive
spencer IN 47460
Manufacturer Contact
carole morley
300 boston scientific way
marlborough, MA 01752
5086834015
MDR Report Key18094627
MDR Text Key327661190
Report Number3005099803-2023-06103
Device Sequence Number1
Product Code LQC
UDI-Device Identifier08714729296386
UDI-Public08714729296386
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K040447
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,Company Representative
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 01/16/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2023
Device Model NumberM00510870
Device Catalogue Number1087
Device Lot Number0030421566
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/22/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/26/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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