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

Model Number	M00510860
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Separation Failure (2547); Adverse Event Without Identified Device or Use Problem (2993); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6 imdrf device code a23 was added to capture use of device issue - misuse as the device was used in the incorrect anatomy.Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a0401 captures the reportable event of pull wire break.Imdrf impact code f2301 captures the pancreatic stent implanted.Block h10: investigation findings the returned trapezoid rx lithotripter basket was analyzed, and it was observed that the sheath was buckled and torn, the pull wire was broken and kinked, the coil was damaged, and the side car rx was pushed back.It was also noted that the basket tip was still attached to the basket wires.The reported events were confirmed.These problems could have occurred due to excessive manipulation when trying to open the stuck basket or when grabbing the stone and applying excessive force to the handle.Additionally, the technique used, or the patient's anatomical conditions could have contributed to the event.It was also noted that the side car rx was pushed back, which was also most likely caused due to the amount of force applied on the thumb ring when attempting to crush the stone.A labeling review was performed which found evidence to suggest that the device was used in a manner inconsistent with the labeled indications.The instructions for use (ifu) states, "trapezoid rx wireguided retrieval basket is not intended for use in the pancreas.", however, it was reported that the device was used in the pancreatic duct.The ifu contains detailed device information and instructions for the device use and there is no evidence that there is any issue with translation, wording, or graphics of the ifu/labeling information.Since this device was not used in the correct anatomy, it is likely that the difficulties that were encountered during the procedure were related to extra pressure that was applied to retract the device from the pancreatic duct once it was not possible to crush the stone.Based on all available information, adverse event related to procedure was selected as the most probable root cause.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the trapezoid rx basket was used in an attempt to remove a stone from the pancreatic duct.The stone was a bit large, in which the basket could not break the stone.An alliance handle was used in an attempt to crush the stone and detach the tip of the basket.However, the basket got stuck in the pancreatic duct.It was also noted that the pull wire was broken.Fortunately, after several mobilizations by opening and closing, the basket was able to be removed.A pancreatic stent was placed, and the procedure ended.There were no patient complications reported as a result of this event.The patient is in inpatient care being monitored and doing well at this time.There is no date as to when the patient will be taken back for examination.Note: the instructions for use (ifu) indicate that this trapezoid rx lithotripter basket is not intended for use in the pancreas.However, the customer reported that the anatomical location of the procedure was at the pancreatic duct.
Additional Manufacturer Narrative
Block h6: imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a0401 captures the reportable event of pull wire break.Imdrf impact code f2301 captures the pancreatic stent implanted.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx lithotripter basket was used in the pancreatic duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the trapezoid rx basket was used in an attempt to remove a stone from the pancreatic duct.The stone was a bit large, in which the basket could not break the stone.An alliance handle was used in an attempt to crush the stone and detach the tip of the basket.However, the basket got stuck in the pancreatic duct.It was also noted that the pull wire was broken.Fortunately, after several mobilizations by opening and closing, the basket was able to be removed.A pancreatic stent was placed, and the procedure ended.There were no patient complications reported as a result of this event.The patient is in inpatient care being monitored and doing well at this time.There is no date as to when the patient will be taken back for examination.

• Brand Name: TRAPEZOID RX
• Common Device Name: 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: 18618998
• Report Number: 3005099803-2024-00199
• Device Sequence Number: 16754437
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040447
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/12/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/19/2024
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 0032684334
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/09/2024
• Supplement Date Received by Manufacturer: 03/22/2024
• Initial Report FDA Received Date: 01/31/2024
• Supplement Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown