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

Model Number M00510890

Device Problems Break (1069); Use of Device Problem (1670); Separation Failure (2547)

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

Event Date 08/11/2023

Event Type  Injury  

Manufacturer Narrative

Block h6: imdrf device code a0401 captures the reportable event of the handle break.

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) stone retrieval procedure performed on (b)(6), 2023.During the procedure, a trapezoid basket was used in an attempt to crush a 2 cm stone, however, the handle broke at the injection port.The stone became trapped inside the basket and a pair of foreign body pliers were used to remove the stone from the basket.Another trapezoid rx basket was used to remove the stone and 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.

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) stone retrieval procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket was used in an attempt to crush a 2 cm stone, however, the handle broke at the injection port.The stone became trapped inside the basket and a pair of foreign body pliers were used to remove the stone from the basket.Another trapezoid rx basket was used to remove the stone and 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

Block h6: imdrf device code a0401 captures the reportable event of the handle break.Block h10: the returned trapezoid rx was analyzed, and a visual inspection found the handle was not broken.The side car rx has remnants of used but was not pushed back.Functional test found the basket would open accordingly.No problems were found.The reported event that the handle was broken was not confirmed.Based on all available information, the technique used by the physician or the way the device was being led through the patient may have led the user of the device to perceive the handle was fractured/ broken or damaged in some way.Therefore, the root cause for this event is no problem detected.

Manufacturer Narrative

Block h2: blocks b5 and h6 have been updated based on additional information received on november 24, 2023.Block h6: imdrf device code a0401 captures the reportable event of the handle break.Imdrf device code a23 captures the reportable event of failure to crush stone.Imdrf device code a150301 captures the reportable event of tip failure to separate.Block h10: the returned trapezoid rx was analyzed, and a visual inspection found the handle was not broken.The side car rx has remnants of used but was not pushed back.Functional test found the basket would open accordingly.No problems were found.The reported event of handle broken, and device failed to crush the stone was not confirmed.Based on all available information, the technique used by the physician or the way the device was being led through the patient may have led the user of the device to perceive the handle was fractured/ broken or damaged in some way.Additionally, the device had remnants of use and the tip of the device was still attached.It is possible that the tip failed to separate due to the remnants or contact with the patient's anatomy when advancing through the bile duct.The most probable cause of the reported event of tip failure to separate is adverse event related to procedure.Overall, the most probable root cause for this event is no problem detected.

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) stone retrieval procedure performed on (b)(6) 2023.During the procedure, a trapezoid basket was used in an attempt to crush a 2 cm stone, however, the handle broke at the injection port.The stone became trapped inside the basket and a pair of foreign body pliers were used to remove the stone from the basket.Another trapezoid rx basket was used to remove the stone and 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.****additional information received on november 24, 2023*** the customer assumed that the handle was broken because they were unable to crush the stone and the tip failed to separate.

• 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: 17673759
• MDR Text Key: 322546458
• Report Number: 3005099803-2023-04690
• 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,Followup
• Report Date: 12/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/19/2024
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031264042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2023
• 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 Age: 42 YR
• Patient Sex: Female
• Patient Weight: 58 KG