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

Model Number M00510890

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/19/2021

Event Type  malfunction  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation, the package was opened and found the basket failed to open.Additionally, a rust was noted on the connecting rod at the far end.The procedure was completed with another trapezoid basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Initial reporter facility name: (b)(6).(b)(4).The device has not been received for analysis.Upon receipt and completion of the problem analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.During preparation, the package was opened and found the basket failed to open.Additionally, a rust was noted on the connecting rod at the far end.The procedure was completed with another trapezoid basket.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

Manufacturer Narrative

Block e1: initial reporter facility name: no.2 affiliated (b)(6) hospital.Block h6: device code a180104 captures the reportable event of foreign material present in device.Block h10: the returned trapezoid rx basket was analyzed, and a visual inspection noted that the basket was not returned.The working length was observed to be kinked and waste was found throughout the device.Due to the basket did not return for analysis, a functional inspection to ensure if the basket open properly could not be performed.Additionally, since the basket did not return for analysis, it's suggested that it was detached.The reported event was not confirmed.Based on all available information, it is possible some technique applied by the customer during procedure, tortuous anatomy, or even preparation could cause difficulty on the normal use of the device and lead to basket detached and working length kinked.Also, the costumer reported that during the preparation the connecting rod at the far end was rusted.However, the visible component of the device which is the basket was not returned for analysis.Therefore, the most probable root cause is adverse event related to procedure since the adverse event occurred during the procedure and the device had no influence on 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: 13733228
• MDR Text Key: 287005852
• Report Number: 3005099803-2022-01206
• 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: 10/18/2022

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: 11/23/2021
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0026411151
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2022
• Initial Date FDA Received: 03/11/2022
• Supplement Dates Manufacturer Received: 09/22/2022
• Supplement Dates FDA Received: 10/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/23/2020
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 136 KG