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

Model Number M00510890

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 09/27/2022

Event Type  malfunction  

Event Description

Note: this report pertains to one of two trapezoid rx baskets used in the same patient and procedure.It was reported to boston scientific corporation that two trapezoid rx baskets were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, the handle of the trapezoid basket was fractured when preparing to use the device.Another trapezoid was used but the same problem occurred during the procedure.The procedure was completed with the third trapezoid rx basket.There were no patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Initial reporter facility name: the first affiliated hospital of pla air force medical university initial reporter address: no.127, west changle road, xincheng district (b)(4).

Event Description

Note: this report pertains to one of two trapezoid rx baskets used in the same patient and procedure.It was reported to boston scientific corporation that two trapezoid rx baskets were used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During preparation, the handle of the trapezoid basket was fractured when preparing to use the device.Another trapezoid was used but the same problem occurred during the procedure.The procedure was completed with the third trapezoid rx basket.There were no patient complications a result of this event.Boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

Manufacturer Narrative

Block e1: initial reporter facility name: (b)(6) hospital.Block h6: device code a0501 captures the reportable event of handle cannula detachment.Block h10: the returned trapezoid rx retrieval basket was analyzed, and a visual inspection noted that the handle cannula was detached, resulting in exposure of the internal pull wire.Additionally, the working length was bent and detached from the handle, the sheath was buckled, and the basket was bent.Although an x-ray showed that the screws were in good condition, the proximal screw depth was measured less than the minimum tolerance defined in the product design specifications.The set screw holds the handle to the cannula of the device, and if the set screw is not fastened to the appropriate depth, it could impact the set screw joint tensile strength during use of the device and cause the handle cannula to detach.It also found that the retrieval basket side car rx was pushed back approximately 1.5 mm, which is out of specification.The observed side car rx push back was likely caused by manipulation of the device during use; possibly during attempts to remove the device after the handle cannula broke.The customer provided three images where it was possible to observe the working length cut and the handle cannula detached.The reported event was confirmed.Based on all available information, it was concluded that the handle cannula detachment event was likely caused by a set screw that was not fastened to the correct depth during manufacturing of the trapezoid rx retrieval basket.An investigation conclusion code of 'quality control deficiency' was assigned, since the process for confirming correct set screw depth was found to be inadequate.A non-conforming events prevention (ncep) and a corrective and preventive action (capa) investigation was initiated to determine the root cause of these types of events and to identify appropriate mitigations.This device was manufactured prior to implementation of these solutions.The separation of the working length from the handle, side car rx push back, sheath buckled, and basket bent may have occurred due to handling consequent to the detachment of the handle cannula.Therefore, the root cause for these problems found during investigation 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.Block h11: block e1 (initial reporter address 1, initial reporter address 2, and initial reporter zip code) have been updated.

• 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: 15751574
• MDR Text Key: 307664749
• Report Number: 3005099803-2022-06488
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• 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: 03/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/28/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029303234
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2022
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 65 KG