MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER TRAPEZOID¿ RX; LITHOTRIPTOR, BILIARY MECHANICAL

Model Number M00510890

Device Problem Separation Failure (2547)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2017

Event Type  malfunction  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon 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.

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) 2017.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid¿ rx basket in an attempt to crush the stone.However, the stone was not crushed and the tip of the basket failed to detach.Reportedly, no additional intervention was needed to remove the device from the patient.The procedure was completed with another trapezoid¿ rx 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

Visual analysis of the returned device found that the basket wire/wire assembly were cut and had been removed from the coil assembly.The basket wires were found to be undeformed and the tip was intact.The end of the basket/wire assembly presented a clean cut likely made with a sharp tool.Additionally, the catheter was found kinked in several locations.Complaint confirmed, the reported issue of tip won't detach could not be functionally verified, however findings from visual evaluation indicate that likely there were issues to detach the tip during procedure.The device is designed so that the basket tip detaches if the stone cannot be crushed however, it is unknown what tensile force was applied to the device during the attempt to detach the tip.Although it cannot be determined how the tip failed to detach, stone size and density, user technique, tortuous anatomy and other procedural factors could possibly contribute to the failure by causing the tensile force applied by the user to not be fully distributed throughout the device.In addition, handling and manipulation of the device during procedure could have contributed with the catheter kinked.Therefore, the most probable root cause of this complaint is "operational context", since it is most likely that due to anatomical and/or procedural factors encountered during the procedure, performance was limited.The device history record (dhr) review found the device met all manufacturing specifications.A search of the complaint database confirmed that no similar complaints exist for the specified lot.

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) 2017.According to the complainant, during the procedure, an alliance handle was used in conjunction with the trapezoid¿ rx basket in an attempt to crush the stone.However, the stone was not crushed and the tip of the basket failed to detach.Reportedly, no additional intervention was needed to remove the device from the patient.The procedure was completed with another trapezoid¿ rx 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.

• Brand Name: TRAPEZOID¿ RX
• Type of Device: LITHOTRIPTOR, BILIARY MECHANICAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer (Section G): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: nancy cutino ; 100 boston scientific way; marlborough, MA 01752 ; 5086834000
• MDR Report Key: 7187217
• MDR Text Key: 97489284
• Report Number: 3005099803-2018-00033
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: 08714729296409
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/19/2017

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: 09/06/2018
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 21100121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/12/2018
• Supplement Dates Manufacturer Received: 01/15/2018
• Supplement Dates FDA Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2017
• 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