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

Model Number M00510890

Device Problems Break (1069); Separation Failure (2547); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/10/2019

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 during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6), 2019.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a 13-15 mm gallstone that was too large to pass through the patient's ampulla in one piece.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.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 wires to deform releasing the stone.The procedure was completed by dilating the ampulla to 18mm with a controlled radial expansion (cre) balloon and the stone was retrieved using a 15-18mm extractor pro.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

Problem code 1069 captures the reportable event of handle cannula broken.Problem code 2547 captures the reportable event of tip failure to separate.One trapezoid lithotripter basket assembly was returned for analysis.The pull wire was received removed from the handle and cut in the distal section, which is consistent with the report that the user cut the handle of the device.The proximal section of the pull wire was not returned.The basket was deformed (bent/kinked).The distal tip was intact and still attached to the basket wire assembly.A test of the tip joint strength could not be performed due to the deformation of the basket wires.No other issues were noted.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.Based on all available information, the investigation concluded that anatomical or procedural factors encountered during the procedure likely affected the device's performance and integrity.Patient anatomy and user maneuvering to reach the intended location can add resistance to the device during actuation of the handle, which can lead to the handle cannula breaking and basket deformation.Although the handle portion of the device was not returned, application of force perpendicular to the finger ring/handle assembly can also lead to the reported detachment of the handle cannula.Therefore, the most probable cause of the event was determined to be adverse event related to procedure.

Event Description

It was reported to boston scientific coporation that a trapezoid rx basket was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2019.According to the complainant, during the procedure, an alliance ii handle was used in conjunction with the trapezoid basket in an attempt to crush a 13-15 mm gallstone that was too large to pass through the patient's ampulla in one piece.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.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 wires to deform releasing the stone.The procedure was completed by dilating the ampulla to 18mm with a controlled radial expansion (cre) balloon and the stone was retrieved using a 15-18mm extractor pro.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: 9153546
• MDR Text Key: 173044541
• Report Number: 3005099803-2019-04827
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/13/2019

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: 06/18/2020
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0023976688
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Initial Date Manufacturer Received: 09/10/2019
• Initial Date FDA Received: 10/03/2019
• Supplement Dates Manufacturer Received: 11/28/2019
• Supplement Dates FDA Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 89 YR