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

Model Number	M00510860
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	09/12/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a complete endoscopic sphincterotomy procedure performed on (b)(6) 2022.During the procedure, the trapezoid rx basket captured a stone.However, the metal sheath tore and there was difficulty removing the device.By force of manipulation, the basket was successfully extracted.The procedure was continued by a new catheterization.Bleeding on the sphincterotomy orifice was noted and a self-expanding metal stent was placed to stop the bleeding.There was an increased procedural time of about 1 hr to 1hr 30 mins.No other patient complications were reported.
Additional Manufacturer Narrative
Block h6: patient code e0506 captures the reportable event of major hemorrhage.Device code a0401 captures the reportable event of pull wire break.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the sheath was cut off, the handle cannula was detached from the pull wire and did not return.In addition, the working length was very kinked, and the sheath was buckled/accordion (including coil assembly).The reported event was confirmed.Based on all available information, it is possible that an intense manipulation of device, technique used, or patient's anatomical condition could have contributed to this event.Since the handle and cannula did not return, it was not possible to carry out a more thorough investigation.Therefore, the most probable root cause for the investigation findings is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a complete endoscopic sphincterotomy procedure performed on (b)(6) 2022.During the procedure, the trapezoid rx basket captured a stone.However, the metal sheath tore and there was difficulty removing the device.By force of manipulation, the basket was successfully extracted.The procedure was continued by a new catheterization.Bleeding on the sphincterotomy orifice was noted and a self-expanding metal stent was placed to stop the bleeding.There was an increased procedural time of about 1hr to 1hr 30 mins.No other patient complications were reported.
Additional Manufacturer Narrative
Block h6: patient code e0506 captures the reportable event of major hemorrhage.Device code a0401 captures the reportable event of pull wire break.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the sheath was cut off, the handle cannula was detached from the pull wire and did not return.In addition, the working length was very kinked, and the sheath was buckled/accordion (including coil assembly).The reported event was confirmed.Based on all available information, it is possible that an intense manipulation of device, technique used, or patient's anatomical condition could have contributed to this event.Since the handle and cannula did not return, it was not possible to carry out a more thorough investigation.Therefore, the most probable root cause for the investigation findings is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Block h11: block h6 component code has been corrected.Block h6 evaluation result code has been corrected.
Event or Problem Description
It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during a complete endoscopic sphincterotomy procedure performed on (b)(6), 2022.During the procedure, the trapezoid rx basket captured a stone.However, the metal sheath tore and there was difficulty removing the device.By force of manipulation, the basket was successfully extracted.The procedure was continued by a new catheterization.Bleeding on the sphincterotomy orifice was noted and a self-expanding metal stent was placed to stop the bleeding.There was an increased procedural time of about 1hr to 1hr 30 mins.No other patient complications were reported.

• 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: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15556317
• Report Number: 3005099803-2022-05598
• Device Sequence Number: 15099371
• Product Code: LQC
• UDI-Device Identifier: 08714729296379
• UDI-Public: 08714729296379
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/05/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2023
• Device Model Number: M00510860
• Device Catalogue Number: 1086
• Device Lot Number: 0029323852
• 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: 09/15/2022
• Supplement Date Received by Manufacturer: 11/28/2022; 12/14/2022
• Initial Report FDA Received Date: 10/06/2022
• Supplement Report FDA Received Date: 12/14/2022; 01/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/02/2022
• 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: Required Intervention
• Patient Sex: Unknown