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

Model Number M00510890

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/05/2022

Event Type  malfunction  

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) 2022.During the procedure, the handle cannula broke.The basket was pulled out and another trapezoid basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Device code a0401 captures the reportable event of handle cannula break.The returned trapezoid rx basket was analyzed, and a visual inspection revealed that the handle cannula was detached and broken.Microscope examination revealed that the handle and handle cannula had been over-manipulated.Dimensional inspection revealed that the sidecar rx had been pushed back approximately 17.5 mm, which was outside of specification.Both the depth and length of the screws were measured and found to be within the allowed tolerances.The screws were found to be in good condition, according to the x-ray results.Media inspection of the photo provided showed the handle cannula detached.No other issues were noted.The reported event "handle cannula break" was confirmed because the analysis performed on the provided image revealed that the handle cannula had become detached.The customer may have misinterpreted the detachment of the handle cannula as a handle breakage.The handle cannula on the returned device was broken, apparently by manipulation after detachment, as indicated by the marks on the plastic handle.Furthermore, the side car rx was pushed back.The evidence suggests that when the handle was pulled, an excessive amount of force was applied; perhaps the technique used, or the patient's anatomical conditions contributed to this event.Therefore, the most probable root cause is adverse event related to procedure.

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) 2022.During the procedure, the handle cannula broke.The basket was pulled out and another trapezoid basket was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following 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
• 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: 16070731
• MDR Text Key: 306847042
• Report Number: 3005099803-2022-07549
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 02/10/2023

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: 06/09/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029556835
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/29/2022
• Supplement Dates Manufacturer Received: 01/23/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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 Age: 62 YR
• Patient Sex: Female
• Patient Weight: 65 KG