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

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2020

Event Type  malfunction  

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 biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket to crush a stone.However, the tip of the basket failed to detach to release the stone.The stone was finally released after several attempts of opening and closing the basket.The basket was then removed through the working channel of the endoscope.The procedure was completed with another trapezoid rx basket.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block h6: device code 2547 captures the reportable event of the tip failure to separate.Block h10: visual analysis of the returned device found the thumb ring of the handle assembly deformed and broken.The sheath was found buckled at the proximal section and was detached from the handle.The side car rx tunnel was found pushed back.The basket was manually opened and did not present any visual damage or abnormalities and the tip was intact and attached to the basket wire assembly.Functional evaluation was unable to be performed due to the condition of the returned device; therefore the reported event of the tip failing to separate cannot be confirmed.Based on all available information, 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 can contribute to this encountered failures.Once the sheath has been detached, the basket would fail to extend as expected, generating issues during the tip release, resulting in the reported complaint.Therefore, the most probable root cause is adverse event related to procedure.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.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2020.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket to crush a stone.However, the tip of the basket failed to detach to release the stone.The stone was finally released after several attempts of opening and closing the basket.The basket was then removed through the working channel of the endoscope.The procedure was completed with another trapezoid rx basket.There were no patient complications as a result of this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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: 10267897
• MDR Text Key: 199523613
• Report Number: 3005099803-2020-02659
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• 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: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/05/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024722068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2020
• Initial Date Manufacturer Received: 06/16/2020
• Initial Date FDA Received: 07/13/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/20/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 56 YR