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

Model Number M00510880

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

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

Event Date 03/21/2023

Event Type  Injury  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore, the expiration and device manufacture dates are unknown.Imdrf device code a150301 captures the reportable event of the basket failed to detached.Imdrf device code a0401 captures the reportable event of the handle cannula broke imdrf device code f23 captures the reportable impact code of unexpected medical intervention.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the billiary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During procedure, a trapezoid rx basket was used in an attempt to crush a 2 cm stone with an alliance handle, however the pull wire and handle cannula broke.Additionally, the basket tip failed to be detached.A lithotripsy was used to remove all the stones from the basket before the trapezoid basket was removed from the patient.The procedure was completed with an ehl & spyscope.There were no patient complications as a result of this event.

Manufacturer Narrative

Block d4, h4: the complainant was unable to report the lot number; therefore, the expiration and device manufacture dates are unknown.Block h6: imdrf device code a150301 captures the reportable event of the basket failed to detached.Imdrf device code a0401 captures the reportable event of the handle cannula broke.Imdrf device code f23 captures the reportable impact code of unexpected medical intervention.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the pull wire was broken and kinked.The basket returned properly attached at the wire, however the handle did not return for analysis.A picture provided by the customer noted wires without the sheath, which indicates the sheath detached.Additionally, the handle or the handle cannula cannot be seen, therefore it is not possible to confirm if the cannula is detached based on the pictures.Lastly, the tip is still intact on the basket.Based on all available information, it is most likely that procedural or anatomical factors encountered during the procedure could have affected the device leading to the reported events.It is possible that excess manipulation could lead to the pull wire kink and additional force used to try to break the stone could lead to the detachment of the pull wire and inability to deploy the tip.Therefore, the most probable root cause for the problems identified during investigation is adverse event related to procedure.However, since the handle or handle cannula cannot be seen, it is not possible to confirm these reported events.Therefore, the most probable root cause for these reported events is cause not established.A device history record (dhr) review was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lots, and a dhr review on the most probable lots did not identify any deviations within manufacturing/service processes that could have contributed to the event.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the billiary tree during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on march 21, 2023.During procedure, a trapezoid rx basket was used in an attempt to crush a 2 cm stone with an alliance handle, however the pull wire and handle cannula broke.Additionally, the basket tip failed to be detached.A lithotripsy was used to remove all the stones from the basket before the trapezoid basket was removed from the patient.The procedure was completed with an ehl & spyscope.There were no patient complications as a result of this event.

• 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; 2546 calle primera; alajuela ; CS
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16732556
• MDR Text Key: 313219322
• Report Number: 3005099803-2023-01874
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/29/2023

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 Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2023
• Initial Date FDA Received: 04/13/2023
• Supplement Dates Manufacturer Received: 06/12/2023
• Supplement Dates FDA Received: 06/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Sex: Female