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

Model Number M00510890

Device Problem Premature Activation (1484)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/15/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).(b)(4).

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic stone removal procedure performed on (b)(6)2022.During insertion, when the trapezoid basket entered the ampulla and continued to advance, the tip of the basket separated resulting in the deformation of basket and becoming unusable.The tip was left in the patient's intestine and could not be removed.The basket was replaced to continue the procedure.The detached tip can be seen under ct imaging.Patient observation and follow-up is required.No patient complications were reported as a result of this event.

Manufacturer Narrative

E1: initial reporter address: (b)(6).H6: device code a150103 captures the reportable event of tip premature deployment.Patient code (b)(6) captures the reportable event of unretrieved device fragment.E1 (initial reporter phone and zip/post) has been updated based on additional information received from intake on 21nov2022.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic stone removal procedure performed on (b)(6) 2022.During insertion, when the trapezoid basket entered the ampulla and continued to advance, the tip of the basket separated resulting in the deformation of basket and becoming unusable.The tip was left in the patient's intestine and could not be removed.The basket was replaced to continue the procedure.The detached tip can be seen under ct imaging.Patient observation and follow-up is required.No patient complications were reported as a result of this event.Additional information received on october 17, 2022.The procedure was completed with another trapezoid basket.The patient is still hospitalized and has been transferred to the hepatobiliary surgery department for continuous observation whether the tip can be naturally discharged from the body.No complications have occurred so far.

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic stone removal procedure performed on (b)(6) 2022.During insertion, when the trapezoid basket entered the ampulla and continued to advance, the tip of the basket separated resulting in the deformation of basket and becoming unusable.The tip was left in the patient's intestine and could not be removed.The basket was replaced to continue the procedure.The detached tip can be seen under ct imaging.Patient observation and follow-up is required.No patient complications were reported as a result of this event.Additional information received on october 17, 2022.The procedure was completed with another trapezoid basket.The patient is still hospitalized and has been transferred to the hepatobiliary surgery department for continuous observation whether the tip can be naturally discharged from the body.No complications have occurred so far.

Manufacturer Narrative

Block e1: initial reporter address: no.3, west of mishan east rd, wendeng district block h6: device code (b)(6) captures the reportable event of tip premature deployment.Patient code e2008 captures the reportable event of unretrieved device fragment.Block h11: blocks b5, d7a, e1 (initial reporter first and last name), e2, e3 have been updated based on additional information received on october 17, 2022.

• 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: 15584551
• MDR Text Key: 301924217
• Report Number: 3005099803-2022-05888
• 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,Followup
• Report Date: 12/09/2022

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: 03/09/2023
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 0029011367
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 10/17/2022; 11/21/2022
• Supplement Dates FDA Received: 11/08/2022; 12/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/09/2022
• 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: 59 YR
• Patient Sex: Female