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); Failure to Disconnect (2541); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/31/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, a trapezoid rx basket was used to retrieve a migrated non-bsc plastic stent; however, the basket got trapped around the stent.The patient underwent open surgery on the same day to have the basket removed.The patient's condition following the surgery was stable and they were admitted beyond the standard of care.
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a1204 captures the reportable event of basket failure to release foreign body.Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a0401 captures the reportable event of basket wire break.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.
Additional Manufacturer Narrative
Blocks d4, h4: the complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.Block h6: imdrf device code a1204 captures the reportable event of basket failure to release foreign body.Imdrf device code a150301 captures the reportable event of tip failure to separate.Imdrf device code a0401 captures the reportable event of basket wire break.Block h11: the content in block h6 has been updated.Imdrf impact code f19 captures the reportable event of surgical intervention.Imdrf impact code f08 captures the reportable event of hospitalization or prolonged hospitalization.
Event or Problem Description
It was reported to boston scientific corporation (bsc) that a trapezoid rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, a trapezoid rx basket was used to retrieve a migrated non-bsc plastic stent; however, the basket got trapped around the stent.The patient underwent open surgery on the same day to have the basket removed.The patient's condition following the surgery was stable and they were admitted beyond the standard of care.Note: photos provided by the customer showed an endoscopic image of the device inside the patient and the device outside the patient.The basket wires are broken, and the tip is still attached.In addition, the broken basket wires and tip are stuck with the plastic stent.

• 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: 19594116
• Report Number: 3005099803-2024-02932
• Device Sequence Number: 18245144
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2024

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 Model Number: M00510860
• Device Catalogue Number: 1086
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 05/31/2024
• Initial Report FDA Received Date: 06/24/2024
• Supplement Report FDA Received Date: 06/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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; Other
• Patient Sex: Unknown