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

Model Number M00510880

Device Problem Separation Failure (2547)

Patient Problems Inflammation (1932); No Code Available (3191)

Event Date 07/09/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the lower bile duct during a stone removal procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a 10mm stone.However, the stone was hard and could not be crushed.Moreover, the basket wire had caught into the stone and the tip of the basket failed to separate to release the stone.The trapezoid was cut in order to use a soehendra lithotripter, but the coil sheath could not be removed and the wire could not be connected to the soehendra lithotripter.The basket was left inside the patient and the procedure was not completed.The patient developed cholangitis due to this event.On (b)(6) 2020, endoscopic balloon dilation (ebd) was performed, and the cholangitis was resolved.On (b)(6) 2020, an electrohydraulic lithotripsy (ehl) procedure was performed but the stone was too hard to be crushed.The patient was sent to open surgery on (b)(6) 2020 where the basket and stones were removed successfully.There were no patient complications after the surgery.

Manufacturer Narrative

Block h6: device code 2547 captures the reportable event of tip failure to separate.Patient code 1932 captures the reported event of cholangitis.Patient code 3191 captures the reported event of procedure aborted and second procedure required to remove the basket.Patient code 3191 captures the reported event of open surgery.Block h10: visual analysis found the proximal section (handle/handle cannula) of the device was not returned for analysis.Under magnification, a mark was observed on the pull wire suggesting that a mechanical tool was used to cut the device.The working length was found severely kinked and the sheath was torn in some areas.The tip was found still attached to the basket-wire assembly.Residues were observed on the device.Based on all available information, it is most likely that the device could have been excessively manipulated during procedure.Working length severely kinked and sheath torn are issues that could have been generated by the manipulation of the device, interaction with the scope or the interacting with other devices.Kinks on the device would affect the overall performance of the device during its use and it could have contributed with the issues experienced by the customer.Therefore, the most probable root cause for the failures found on the device is adverse event related to procedure.Additionally, the directions for use (dfu) states "in the event that the trapezoid rx wireguided retrieval basket will not crush the calculus, the basket tip has not disengaged and the calculus cannot be removed from the basket, follow clinical and/or surgical standards of practice", therefore the reported issue of "surgery" is noted within the dfu.It also mentions "stone impaction" and "cholangitis" as possible complications and they are noted within adverse events section of the dfu.Therefore, the most probable root cause of this event is known inherent risk of device.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the lower bile duct during a stone removal procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a 10mm stone.However, the stone was hard and could not be crushed.Moreover, the basket wire had caught into the stone and the tip of the basket failed to separate to release the stone.The trapezoid was cut in order to use a soehendra lithotripter, but the coil sheath could not be removed and the wire could not be connected to the soehendra lithotripter.The basket was left inside the patient and the procedure was not completed.The patient developed cholangitis due to this event.On (b)(6) 2020, endoscopic balloon dilation (ebd) was performed, and the cholangitis was resolved.On (b)(6) 2020, an electrohydraulic lithotripsy (ehl) procedure was performed but the stone was too hard to be crushed.The patient was sent to open surgery on (b)(6) 2020 where the basket and stones were removed successfully.There were no patient complications after the surgery.

• 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: 10378809
• MDR Text Key: 202019022
• Report Number: 3005099803-2020-03179
• 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: 09/25/2020

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: 01/05/2021
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0024993600
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Initial Date Manufacturer Received: 07/09/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 09/03/2020
• Supplement Dates FDA Received: 09/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention