MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION TRAPEZOID RX; LITHOTRIPTOR, BILIARY MECHANICAL

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.

• 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 Key: 9446751
• MDR Text Key: 175232758
• Report Number: 3005099803-2019-05967
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• 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 Date: 09/19/2020
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0024465240
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 12/13/2019
• Supplement Dates FDA Received: 01/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention