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

Model Number M00510870

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/14/2020

Event Type  Injury  

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 bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, a trapezoid rx basket was used in an attempt to remove a 1 cm stone.However, the tip of the basket failed to separate when pressure was applied on the device and the basket wire broke at the opposite end however, it remained attached to the device.Additionally, the pull wire was broken.The stone was released from the basket once the basket wire broke.A balloon sweep was performed to remove the broken basket from the patient.The procedure was completed with another trapezoid basket.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block h6: device code 1069 captures the reportable event of basket and pull wire break.Device code 2547 captures the reportable event of tip failure to separate.Block h10: visual inspection of the returned device found the that the tip was attached to the basket when it was received.Therefore, the reported complaint is confirmed.The working length was kinked in several locations.The sidecar rx tunnel was found torn and was pushed back 4 mm which is out of specification.The sheath was torn/ buckled in some locations.The handle cannula was also detached and it was found inside of the working length indicating that an excessive force was applied to the device.The distal screw and proximal screw depth were measured and both were found within specification.X-ray test was performed and no issues were found.Based on all available information, the investigation concluded that procedural and anatomical factors encountered during the procedure could have affected the device's performance and integrity.Handling and manipulation of the device during its use can lead to the handle cannula pulling out from the finger ring and kinks in the working length.Interaction with other devices could have also contributed to the tear of the sheath and pushed back of sidecar rx tunnel.Drag marks were observed indicating that a lot of force was applied to the handle to crush the stone or retract the basket.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 endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.Acording to the complainant, during the procedure, a trapezoid rx basket was used in an attempt to remove a stone.However, the tip of the basket failed to separate when pressure was applied on the device.Reportedly, the basket broke at the proximal part and was difficult to dislodge from the stone and patient's bile duct.There were no patient complications reported as a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 10667326
• MDR Text Key: 211044871
• Report Number: 3005099803-2020-04435
• 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: 11/11/2020

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: 07/23/2021
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0025760091
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2020
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 10/12/2020
• Supplement Dates Manufacturer Received: 10/15/2020
• Supplement Dates FDA Received: 11/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention