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

Model Number M00510880

Device Problems Break (1069); Detachment of Device or Device Component (2907); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Hemorrhage/Bleeding (1888); Injury (2348)

Event Date 12/09/2019

Event Type  Injury  

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 basket was used during a stone extraction procedure on (b)(6) 2019.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to remove a stone.However, the pull wire broke during lithotripsy.A biopsy forceps was used to remove the stone from the basket, a grasper was used to remove the trapezoid basket and two stents were placed.Reportedly, the patient experienced retropneumoperitoneum post procedure due to the difficulty in completing the procedure.

Manufacturer Narrative

Block h2: additional information: blocks b5 and h6 (patient and device codes) have been updated based on additional information received.Block h6: problem code 2907 captures the reportable event of handle cannula detached.Block h10: 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 during a stone extraction procedure on (b)(6), 2019.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to remove a stone.However, the pull wire broke during lithotripsy.A biopsy forceps was used to remove the stone from the basket, a grasper was used to remove the trapezoid basket and two stents were placed.Reportedly, the patient experienced retropneumoperitoneum post procedure due to the difficulty in completing the procedure.***additional information received from (b)(6) 2019 - (b)(6) 2019*** it was reported that the size of the stone was about 12 mm.The device broke upon closing the handle of the trapezoid basket over the stone without using an alliance handle.Maneuvering was performed to remove the basket from the stone and from the patient, resulting in bleeding.A plastic and a metallic stent were placed to drain the bile duct.The patient did not experience retropneumoperitoneum post procedure.There was no further intervention performed.The complainant provided photographs of the device, which showed the pull wire was not broken, the handle cannula was kinked and detached from the handle and the pull wire was kinked.

Manufacturer Narrative

Block h2: additional information: blocks b5 and h6 (patient and device codes) have been updated based on additional information received.Block h6: problem code 2907 captures the reportable event of handle cannula detached.Block h10: visual inspection of the returned device found the handle was kinked and the handle cannula was pulled out of the finger ring portion of the handle assembly.The basket-wire assembly was completely removed from the device.Additionally, the working length was kinked in several locations.Both dimples 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.With all the available information, boston scientific concludes it is most likely that procedural or anatomical factors encountered during the procedure affected the device's performance and integrity.Handling and manipulation of the device can lead to device kink/bent which likely affects the overall performance of the device during its use.Kinks can also cause friction between device components at kink/bent areas making it difficult to actuate the device.Continued attempts to actuate the handle can lead to handle cannula kink and 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.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.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu).Additionally, the reported bleeding is noted within the directions for use (dfu) as a possible complication.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used during a stone extraction procedure on (b)(6) 2019.According to the complainant, during the procedure, a trapezoid basket was used in an attempt to remove a stone.However, the pull wire broke during lithotripsy.A biopsy forceps was used to remove the stone from the basket, a grasper was used to remove the trapezoid basket and two stents were placed.Reportedly, the patient experienced retropneumoperitoneum post procedure due to the difficulty in completing the procedure.***additional information received from (b)(6), 2019 - (b)(6), 2019*** it was reported that the size of the stone was about 12 mm.The device broke upon closing the handle of the trapezoid basket over the stone without using an alliance handle.Maneuvering was performed to remove the basket from the stone and from the patient, resulting in bleeding.A plastic and a metallic stent were placed to drain the bile duct.The patient did not experience retropneumoperitoneum post procedure.There was no further intervention performed.The complainant provided photographs of the device, which showed the pull wire was not broken, the handle cannula was kinked and detached from the handle and the pull wire was kinked.

• 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: 9555721
• MDR Text Key: 173849047
• Report Number: 3005099803-2019-06379
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• 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,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: 10/07/2020
• Device Model Number: M00510880
• Device Catalogue Number: 1088
• Device Lot Number: 0024561769
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2020
• Initial Date Manufacturer Received: 12/10/2019
• Initial Date FDA Received: 01/06/2020
• Supplement Dates Manufacturer Received: 01/03/2020; 02/20/2020
• Supplement Dates FDA Received: 01/29/2020; 03/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention