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

Model Number M00510870

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 07/27/2022

Event Type  Injury  

Event Description

It was reported to boston scientific corporation that a trapezoid rx basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, upon closing the basket, the basket detached from the catheter.The basket was stuck in the common bile duct which needs to be removed by surgery.The surgery was performed on the same day.

Manufacturer Narrative

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

Manufacturer Narrative

Block h2: additional information: b5 (event description) has been updated, based on additional information received.Block h6: impact code f1901, captures the reportable event of additional surgery.Impact code f08, captures the reportable issue of hospitalization or prolonged hospitalization.Device code a0501, captures the reportable event of basket detachment of device or device component.Block h10: the returned trapezoid rx basket was analyzed, and a visual evaluation noted, that the handle cannula was detached.And was not returned along with the internal wire and the basket.The working length was found bent and the side car rx was torn.Dimensional inspection observed, the side car rx was pushed back approximately 5.5 mm.Which is out of specification.The depth of the fastening screws was measured and found two of the proximal screws were out of the allowed tolerance.The length of the screws is within the allowed tolerance.No other issues with the device were noted.Based on all available information, it is most likely that, due to the unsuitable depth of the proximal screw, that handle cannula was not fastened properly.It is most likely, that when force was applied upon activation of the device, the handle cannula detached.Additionally, the detachment of the handle cannula in conjunction with the manipulation, during the procedure could have caused the working length bent/kinked, side car - rx torn, and side car - rx pushback.Therefore, the most probable root cause of the investigation finding handle cannula detached is manufacturing deficiency.As the problems was traced to the manufacturing process.The root cause of the investigation finding of working length bent/kinked, side car - rx torn, and side car - rx pushback is adverse event related to procedure, since these issues could have been caused by the detachment of the handle cannula in conjunction with the manipulation, during the procedure.A labeling review was performed.And from the information available, this device was used, per the instructions for use (ifu)/product label.

Event Description

It was reported, to boston scientific corporation.That a trapezoid rx basket was used in the common bile duct, during an endoscopic retrograde cholangiopancreatography (ercp) procedure, performed on (b)(6) 2022.During the procedure, an alliance handle was used in conjunction with the trapezoid basket in an attempt to crush a stone.However, upon closing the basket, the basket detached from the catheter.The basket was stuck in the common bile duct, which needs to be removed by surgery.The surgery was performed on the same day.Additional information received on (b)(6) 2022 the stuck basket was removed from the patient via an emergency surgery, that was performed on the same event/procedure date (b)(6) 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: 15275772
• MDR Text Key: 298399410
• Report Number: 3005099803-2022-04737
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/16/2023
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 0029409437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/01/2022
• Initial Date FDA Received: 08/23/2022
• Supplement Dates Manufacturer Received: 10/13/2022
• Supplement Dates FDA Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/16/2022
• 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 Outcome(s): Hospitalization; Required Intervention