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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 M00510890
Device Problems Break (1069); Separation Failure (2547); Difficult to Open or Close (2921)
Patient Problem Patient Problem/Medical Problem (2688)
Event Date 04/27/2020
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 complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the basket got stuck around the stone and would not release the stone.The tip failed to release from the basket so an alliance handle was used in conjunction with the basket to release the tip.However, this was unsuccessful as the thumb ring of the trapezoid handle broke instead.A soehendra lithotripter was used to attempt to detach the tip in order to remove the basket from the patient, but that was unsuccessful as well.The patient was sent to the operating room for an open common bile duct (cbd) exploration.It was noted that the patient issue is ongoing.
 
Manufacturer Narrative
H10 block h2: additional information: blocks a2, a3, b2, b5, b6 block a2: the exact patients age is unknown.However, it was reported that the patient was "40ish" years old.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 1069 captures the reportable event of thumb ring break device code 2921 captures the reportable event of basket failure to release stone.Device code 2547 captures the reportable event of tip failure to separate.Block h10: the complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the basket got stuck around the stone and would not release the stone.The tip failed to release from the basket so an alliance handle was used in conjunction with the basket to release the tip.However, this was unsuccessful as the thumb ring of the trapezoid handle broke instead.A soehendra lithotripter was used to attempt to detach the tip in order to remove the basket from the patient, but that was unsuccessful as well.The patient was sent to the operating room for an open common bile duct (cbd) exploration.It was noted that the patient issue is ongoing.***additional information received on (b)(6) 2020*** the stone was revealed to be greater than 3cm and was lodged in the mid-to-proximal duct with proximal ductal dilation and normal caliber distal duct.Lithotripsy was first attempted by electrohydraulic lithotripsy (ehl) but failed due to the extremely hard stone.Three probes managed to reduce the stone size to approximately 2.5cm.When in the operating room, the patient was kept intubated and under general anesthesia, and the patient was explored via an open surgical approach.The gallbladder was found to be fused to the cbd with a fistula between the gallbladder and the bile duct.When the two structures were separated, the surgeon could see the stone and basket in the cbd through the fistula opening.The stone and basket were removed, as well as the gallbladder.The surgeon noted an injury to the right hepatic duct.The injury was managed by repairing it primarily and then placing a plastic stent up into the right hepatic duct and across the area of injury with the distal end extending into the distal bile duct.The fistula opening in the bile duct was then closed primarily and a drain left in the area.Post-operatively, the patient did well with only a small amount of bile seen in his drain during the early days of recovery.This resolved spontaneously.He was hospitalized for a total of approximately 7 days and then discharged home.Approximately 10 days post-op, dr.Thosani repeated an ercp to evaluate the duct, ensure there was no leak, and exchange the surgically placed stent for an endoscopic one.The ercp revealed no leak, stricture, or retained stone material.The surgically placed stent was removed and an endoscopic one was placed.His surgical drain was removed some time after this procedure.The patient has been seen once in follow up by dr.Thosani and also by his surgeon.The patient is doing well with no complications from the surgery.It was noted that given the patient s pathology (i.E.Fistula between gallbladder and bile duct), the patient would have required surgery regardless.
 
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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 Key10080539
MDR Text Key191803985
Report Number3005099803-2020-02029
Device Sequence Number1
Product Code LQC
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 07/14/2020
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 NumberM00510890
Device Catalogue Number1089
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 04/27/2020
Initial Date FDA Received05/21/2020
Supplement Dates Manufacturer Received06/16/2020
Supplement Dates FDA Received07/14/2020
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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