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

Model Number M00510890

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/11/2019

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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in attempt to crush a 1.5cm size stone.However, the handle cannula of the trapezoid basket broke during the attempt, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's bile duct.A soehendra lithotripter handle was then attached to the wire of the basket to remove the stone from the basket and the basket was successfully removed from the patient's bile duct.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be stable.

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), 2019.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid basket in attempt to crush a 1.5cm size stone.However, the handle cannula of the trapezoid basket broke during the attempt, entrapping the stone inside the basket and causing the basket to become stuck inside the patient's bile duct.A soehendra lithotripter handle was then attached to the wire of the basket to remove the stone from the basket and the basket was successfully removed from the patient's bile duct.There were no patient complications reported as a result of this event.The patient's condition post procedure was reported to be stable.

Manufacturer Narrative

Block h6: problem code 1069 captures the reportable event of handle cannula break.Block h10: visual inspection of the returned device found the handle cannula was pulled out of the finger ring portion of the handle 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 thumb ring was damaged, whitened areas on the material suggest that the component was submitted to a lot of tension.The distal and proximal screw depth were measured and found to be 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 of the device can lead to handle cannula pulling out from the finger ring.The drag marks in the handle cannula indicates that excessive force was applied to the handle to crush the stone resulting in handle cannula detachment.An excessive force applied to the device can also lead to thumb ring damaged; thus, the whitened areas on the thumb ring confirmed that an excessive force was applied to the device.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.

• 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: 9437668
• MDR Text Key: 189764087
• Report Number: 3005099803-2019-05906
• 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: 02/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/25/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0024016007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2019
• Date Manufacturer Received: 01/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1