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

Model Number M00510890

Device Problems Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 07/11/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the duodenal papillary orifice on an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.During procedure, the basket was unable to enter the common bile duct because the sidecar sheath was deformed.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block a1: patient identifier: (b)(6).Block e1: (b)(6).Block h6: imdrf device code a0406 captures the reportable event of sidecar pushback.

Manufacturer Narrative

Block a1: patient identifier: (b)(6).Block e1: (b)(6).Block h6: imdrf device code a0406 captures the reportable event of sidecar pushback.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection observed that that the side car rx was pushed back and the sheath was buckled at the proximal section near the handle.A dimensional test was performed and confirmed the side car rx was pushed back approximately 4.5 mm, which is out of specification.Based on all available information, the problems found suggest that the device was subjected to a level of stress at the time of use.It is possible this could have been caused by various factors, including the manipulation, technique used or the patient's specific anatomical conditions.Therefore, the most probable root cause is adverse event related to procedure.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the duodenal papillary orifice on an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2023.During procedure, the basket was unable to enter the common bile duct because the sidecar sheath was deformed.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: 17475045
• MDR Text Key: 320632353
• Report Number: 3005099803-2023-04211
• Device Sequence Number: 1
• Product Code: LQC
• 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
• Report Date: 09/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/29/2024
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0031337899
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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 Age: 73 YR
• Patient Sex: Male
• Patient Weight: 60 KG