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

Model Number M00510870

Device Problem Break (1069)

Patient Problems Pancreatitis (4481); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/24/2022

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 medwatch 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) 2022.During the procedure, a trapezoid rx basket was used in an attempt to manually crush a 1cm stone.However, the handle cannula of the trapezoid basket broke leaving the stone stuck inside the basket.The wire was cut and the handle was replaced with an olympus emergency lithotriptor handle to break the stone and remove the basket.The patient's condition at the conclusion of the procedure was reported to be stable.However, a day after the procedure the patient was symptomatic for pancreatitis.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of handle cannula break.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the handle cannula was detached and the side car was pushed back out of specification.The internal wires were returned separated from the device.The working length was cut off, the sheath was kinked, and the basket was bent with the tip attached.The depth and length of the fastening screws were measured, and these measurements were within tolerances.A microscope inspection noted the handle cannula has drag marks from the fastening screws.No other issues were noted the reported event was confirmed.Based on all available information, the device could have been affected by the technique used, patient's tortuosity or anatomical conditions confronted during the procedure.Drag marks from the fastening screws indicates that excess force may have been applied.The cut working length suggest that there was over-manipulation, possibly when trying to remove the basket.The issues of side car rx - push back, sheath kinked, and basket bent could have occurred as consequences of the separation of the handle cannula, or when cutting the working length.The most probable root cause for the reported event and the investigation findings is adverse event related to procedure.The adverse event "pancreatitis" is listed in the instructions for use (ifu), and is known as a possible complication thus the conclusion code is "known inherent risk of device." block h10: block h6 patient code and impact code have been corrected.

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) 2022.During the procedure, a trapezoid rx basket was used in an attempt to manually crush a 1cm stone.However, the handle cannula of the trapezoid basket broke leaving the stone stuck inside the basket.The wire was cut and the handle was replaced with an olympus emergency lithotriptor handle to break the stone and remove the basket.The patient's condition at the conclusion of the procedure was reported to be stable.However, a day after the procedure the patient was symptomatic for pancreatitis.

• Brand Name: TRAPEZOID RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15090563
• MDR Text Key: 304628767
• Report Number: 3005099803-2022-03843
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/08/2022

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: 05/16/2023
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0029409437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2022
• Initial Date FDA Received: 07/24/2022
• Supplement Dates Manufacturer Received: 08/18/2022
• Supplement Dates FDA Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention