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

Model Number M00510890

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2019

Event Type  malfunction  

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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6) 2019.According to the complainant, during the procedure, the tip of the basket prematurely detached without any lithotripsy.The tip of the basket was left to pass naturally and the procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be good.

Manufacturer Narrative

Block h6: device codes 1484 captures the reportable event of tip prematurely deployment.Block h10: visual inspection of the device found that the basket wire assembly was in an open position and the tip was detached from the basket assembly.Additionally, the tip was not returned along with the device.No other visual damage was found.Based on all available information, the investigation concluded that the procedural and anatomical factors encountered during the procedure likely affected the device's performance and integrity.Additionally, since the tip of the trapezoid basket is designed to disengage and to minimize the potential risk of unreleased stone entrapment based on the dfu instructions, the most probable root cause of the reported issue of tip premature deployment 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 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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) on (b)(6), 2019.According to the complainant, during the procedure, the tip of the basket prematurely detached without any lithotripsy.The tip of the basket was left to pass naturally and the procedure was completed with another trapezoid rx basket.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be good.

• 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: 9488982
• MDR Text Key: 189840628
• Report Number: 3005099803-2019-06101
• 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: 02/13/2020

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: 07/12/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024101571
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2019
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/18/2019
• Supplement Dates Manufacturer Received: 01/20/2020
• Supplement Dates FDA Received: 02/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1