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

Model Number M00510870

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 04/22/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch 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 (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle of the device lost all tactile feel and broke.Hemostat was used to pull the basket out of the patient.During the removal of the basket, there was trauma to the patient's cbd and ampulla which resulted in slight bleeding.The stone was not removed, and a plastic stent was placed inside the patient.No additional patient complications have been reported as a result of this event, and the procedure was rescheduled for a future date.

Event Description

It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle of the device lost all tactile feel and broke.Hemostat was used to pull the basket out of the patient.During the removal of the basket, there was trauma to the patient's cbd and ampulla which resulted in slight bleeding.The stone was not removed, and a plastic stent was placed inside the patient.No additional patient complications have been reported as a result of this event, and the procedure was rescheduled for a future date.

Manufacturer Narrative

Block h6: device code 1069 captures the reportable event of handle break.Problem code 3191 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: visual inspection of the returned device found the handle cannula detached from the handle.The wire assembly had been pulled out from its original position when the device was received.Additionally, the working length was kinked in several locations.The tip was intact and still attached to the basket assembly.Both dimples from the screws were visible at proximal section of the handle cannula and drag marks were present from dimples towards the proximal end, as the handle cannula had been forcibly pulled out from the set screws.The distal screw and proximal screw depth were measured, and both were found within specification.Based on all available information, the investigation concluded that procedural and anatomical factors encountered during the procedure likely affected the device's performance and integrity.Handling and manipulation can lead to kink/bend of the device, which can cause friction during the basket extension/retraction and resulting in handle cannula detachment.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.Additionally, the reported bleeding is noted within the directions for use (dfu) as a possible complication.

• 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: 10072495
• MDR Text Key: 191529217
• Report Number: 3005099803-2020-01973
• 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,health
• Type of Report: Initial,Followup
• Report Date: 06/25/2020

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: 02/05/2021
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0025167201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/13/2020
• Initial Date Manufacturer Received: 04/22/2020
• Initial Date FDA Received: 05/19/2020
• Supplement Dates Manufacturer Received: 06/01/2020
• Supplement Dates FDA Received: 06/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention