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

Model Number M00510890

Device Problems Break (1069); Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2019

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 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, a trapezoid basket was used in an attempt remove a 13 to 15mm size gallstone.However, the stone was to large to pass through the ampulla so the physician decided to crush the stone.The handle of the basket was then placed in the alliance handle and attempt to crush the stone but the handle cannula broke leaving the stone stuck inside the basket.In order to remove the stone from the basket, the physician cut the handle from the device and exchange the duodenoscope.A soehendra lithotripter handle was then attached to the wire of the basket and attempt to crush the stone or detached the tip of the basket.However, the tip of the basket failed to detach but the pressure caused the basket to deform releasing the stone.A plastic stent was placed across the stricture and the patient was rescheduled for procedure (ercp, spy, and ehl).There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Device code 1069 captures the reportable event of handle cannula broke.Device code 2547 captures the reportable event of tip failure to separate.Only the basket wire assembly was returned for analysis.Visual inspection of the device found that the basket pull wire was kinked/bent in several locations.The basket did not present any visual damage or abnormalities and the tip was intact and it was still attached to the basket wires assembly.The basket tip joint strength was measured and was found to be within specifications.Based on all available information, the investigation concluded that procedural or anatomical factors encountered during the procedure likely affected the device's performance and integrity.Anatomical factors and user maneuvering to reach the intended location can cause resistance during handle actuation and can lead to handle cannula break and pull wire kinked/bent.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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2019.According to the complainant, during the procedure, a trapezoid basket was used in an attempt remove a 13 to 15mm size gallstone.However, the stone was to large to pass through the ampulla so the physician decided to crush the stone.The handle of the basket was then placed in the alliance handle and attempt to crush the stone but the handle cannula broke leaving the stone stuck inside the basket.In order to remove the stone from the basket, the physician cut the handle from the device and exchange the duodenoscope.A soehendra lithotripter handle was then attached to the wire of the basket and attempt to crush the stone or detached the tip of the basket.However, the tip of the basket failed to detach but the pressure caused the basket to deform releasing the stone.A plastic stent was placed across the stricture and the patient was rescheduled for procedure (ercp, spy, and ehl).There were no patient complications as a result of this event.The patient's 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: 8950270
• MDR Text Key: 156177445
• Report Number: 3005099803-2019-04317
• 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: 12/05/2019

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: 03/04/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0023437140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2019
• Initial Date Manufacturer Received: 08/08/2019
• Initial Date FDA Received: 08/30/2019
• Supplement Dates Manufacturer Received: 11/27/2019
• Supplement Dates FDA Received: 12/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 88 YR