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

Model Number M00510890

Device Problem Break (1069)

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

Event Date 12/03/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was inserted into the biliary tract through the nipple.However, when the basket was deployed for lithotripsy, the basket wire broke, but was still attached to one end.The basket was taken out and another trapezoid rx basket was used and completed the procedure.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: device code a0401 captures the reportable event of basket wire break.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation observed that a wire of the basket was detached from the tip, and the tip of the basket shows a tension tear mark.Dimensional inspection found the sidecar rx was pushed back approximately 2.0 mm, which is out of specification.The reported event was confirmed.Based on all available information, it is possible that due to excess force applied; an excess of manipulation, perhaps the technique used, or patient's anatomical conditions could have contributed to this event.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available the device was used per the instructions for the use (ifu)/product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, a trapezoid rx basket was inserted into the biliary tract through the nipple.However, when the basket was deployed for lithotripsy, the basket wire broke, but was still attached to one end.The basket was taken out and another trapezoid rx basket was used and completed the procedure.There were no patient complications reported as a result of this event.

• 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: 16045715
• MDR Text Key: 308351085
• Report Number: 3005099803-2022-07684
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029092669
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2022
• Initial Date FDA Received: 12/23/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 02/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2022
• 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: 56 YR
• Patient Sex: Male
• Patient Weight: 63 KG