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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 Separation Failure (2547); Difficult to Open or Close (2921)
Patient Problems Hemorrhage/Bleeding (1888); Inflammation (1932); Perforation (2001); No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 11/13/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used to address a stone in the common bile duct during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was not possible to extract stone.The basket blocked around the stone.A foreign body retrieval forceps was used to extract the basket and a stent was deployed for drainage.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.
 
Event Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used to address a stone in the common bile duct during a procedure performed on (b)(6) 2019.According to the complainant, during the procedure, it was not possible to extract stone.The basket blocked around the stone.A foreign body retrieval forceps was used to extract the basket and a stent was deployed for drainage.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.***additional information received (b)(6), 2019- (b)(6) 2020*** the procedure date was (b)(6) 2019 as previously reported.The procedure was an endoscopic retrograde cholangiopancreatography (ercp).The basket failed to crush the stone and the tip failed to detach entrapping the stone inside the basket.Maneuvering was performed to pull the basket out of the stone causing bleeding.Reportedly, the patient's bile duct was ripped when trying to extract the stone.The patient was admitted to intensive care in another hospital for suspected pneumothorax due to the ercp procedure.The patient underwent surgery for the suspect pneumothorax; however, it was determined that there was no pneumothorax.The patient was reported to be suffering from severe pancreatitis.
 
Manufacturer Narrative
Block h6: device code 2547 captures the reportable event of tip failure to separate.Patient code 3191 captures the reported event of surgery.Conclusion code 4316 is being used in lieu of an adequate conclusion code for device not returned block h10: according to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
 
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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 Key9446751
MDR Text Key175232758
Report Number3005099803-2019-05967
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 01/10/2020
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 Expiration Date09/19/2020
Device Model NumberM00510880
Device Catalogue Number1088
Device Lot Number0024465240
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/13/2019
Initial Date FDA Received12/10/2019
Supplement Dates Manufacturer Received12/13/2019
Supplement Dates FDA Received01/10/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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