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

Model Number M00510880

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/17/2019

Event Type  Injury  

Manufacturer Narrative

(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental a will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, towards the end of the procedure, an attempt to crush a 2 cm stone using the trapezoid basket was performed; however the stone would not break.Furthermore, the stone became lodged in the basket, and the tip of the basket failed to detach to release the stone.The handle was then cut, and a soehendra lithotripter was attached to attempt to crush the stone, but it was unsuccessful.A spyglass device was then used to break up the stone inside the basket, and they finally were able to get the basket out of the patient and complete the case.There were no patient complications reported as a result of this event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2019.According to the complainant, towards the end of the procedure, an attempt to crush a 2 cm stone using the trapezoid basket was performed; however the stone would not break.Furthermore, the stone became lodged in the basket, and the tip of the basket failed to detach to release the stone.The handle was then cut, and a soehoendra lithotripter was attached to attempt to crush the stone, but it was unsuccessful.A spyglass device was then used to break up the stone inside the basket, and they finally were able to get the basket out of the patient and complete the case.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Device code 2547 captures the reportable event of the tip failure to separate.Visual examination of the device found that the basket wires were found to be deformed and the tip was intact and still attached to the basket wires assembly.The wire basket/wire assembly had been removed from the coil and handle assemblies, including the handle cannula.The wire assembly was cut in three sections, cut ends appear to have been made with a sharp tool.Functional analysis was unable to be performed due to the condition of the device.Since the issue occurred during procedure, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Handling and manipulation of the device during its use or interaction with another device can lead to the basket wires bending.However, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event of the tip detaching prematurely; therefore, the most probable root cause is cause not established.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications.

• 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: 8457933
• MDR Text Key: 140078392
• Report Number: 3005099803-2019-01372
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/10/2019

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: 10/18/2019
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0022813088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/19/2019
• Initial Date Manufacturer Received: 02/28/2019
• Initial Date FDA Received: 03/27/2019
• Supplement Dates Manufacturer Received: 05/13/2019
• Supplement Dates FDA Received: 06/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention