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

Model Number M00510870

Device Problem Separation Failure (2547)

Patient Problem No Code Available (3191)

Event Date 01/07/2020

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 mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to crush a stone; however, the safety tip did not work.The basket could not be removed from the patient's duct.The patient required an emergency surgery to remove the basket.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 basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to crush a stone; however, the safety tip did not work.The basket could not be removed from the patient's duct.The patient required an emergency surgery to remove the basket.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Device code 2547 captures the reportable event of tip failure to separate.Patient code 3191 captures the patient code of surgery.Visual inspection of the returned device found the device was cut in some sections.The wire-basket assembly and coil assembly was returned separated.The handle, handle cannula, and a section of the basket wire assembly were not returned.The tip was attached to the basket assembly when it was received.The device was severly kinked in some sections.The cut section was inspected under magnification and marks observed on the area indicate that it was intentionally cut with an unknown tool.Based on all available information, it is likely that during the procedure the device could have been excessively manipulated, since the failure of device kink is an issue that could have been generated by manipulation of the device, and interaction with the scope or 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 is adverse event related to procedure.Additionally, the reported issue of surgery is noted within the directions for use (dfu).The directions for use states that in the event that the basket does not crush the calculus and the basket tip has not disengaged and calculus can not be removed from the basket, follow clinical and/or surgical standards of practice.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.

• 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: 9654868
• MDR Text Key: 188328185
• Report Number: 3005099803-2020-00159
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• 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: 03/17/2020

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: 10/10/2020
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0024584632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 01/08/2020
• Initial Date FDA Received: 01/31/2020
• Supplement Dates Manufacturer Received: 02/19/2020
• Supplement Dates FDA Received: 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention