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

Model Number 1088

Device Problems Difficult to Open or Close (2921); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/19/2023

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the bile duct during a lithotripsy procedure performed on (b)(4), 2023.During the procedure, the basket entered the biliary tract to retrieve the stone and could not be opened.Another trapezoid rx basket was used to complete the procedure.There were no patient complications as a result of this event.Note: investigation results revealed the side car rx tunnel was pushed back out of specification; therefore, this is now an mdr reportable event (see block h10 for investigation details).

Manufacturer Narrative

Block e1: initial reporter address: (b)(6).Block h6: imdrf device code a051104 captures the reportable investigation report of side car rx push back.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted that the sheath was buckled and detached.A dimensional test was performed and confirmed that the side car rx was pushed back 3.5 mm, which is out of specification.Additionally, a function test was performed by attempting to open the basket, however it was not possible because the coil was detached from the device affecting its functionality.No other issues were noted.The reported event of basket failure to open was confirmed.Based on all available information, the coil detachment and separation of the sheath, along with buckling, suggests a possible elongation of the coil while attempting to open the basket.The side car rx was also pushed back, indicating excessive force may have contributed to the event along with the patient's anatomical conditions.Therefore, the most probable root cause is adverse event related to procedure.

• 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: 17704297
• MDR Text Key: 322950284
• Report Number: 3005099803-2023-04675
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296393
• UDI-Public: 08714729296393
• 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
• Report Date: 09/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/03/2023
• Device Model Number: 1088
• Device Catalogue Number: 1088
• Device Lot Number: 0030473094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/03/2022
• 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: 52 YR
• Patient Sex: Male
• Patient Weight: 76 KG