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

Model Number M00510890

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2016

Event Type  Injury  

Manufacturer Narrative

Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(6).(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 mdr 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) with stone extraction procedure on (b)(6) 2016.According to the complainant, during the procedure, a calculus was captured with the trapezoid basket in the common bile duct.However, the handle broke while attempting to withdraw the calculus.A different basket was used to remove the calculus from the trapezoid basket and to complete the procedure.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 the side car-rx was torn and presented pushback out of specification.Additionally, the thumb ring was found detached from the handle.Both thumb ring and handle show coincident marks that indicate proper assembly.A functional evaluation was done by assembling the thumb ring back into the handle and revealed that the device opened and closed without issue.Evaluation concluded that most likely during procedure the device could have been excessively manipulated since the failure side car-rx pushback and torn are issues that could have been generated by the manipulation of the device, the interaction with the scope or other devices.Moreover, the thumb ring was pulled out of handle assembly, probably due to excessive force applied to the handle when attempting to remove the calculus.Therefore, the most probable root cause is "operational context" since 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 revealed that no similar complaints exist for the specified lot.A labeling review was performed and no anomaly was found.

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) with stone extraction procedure on (b)(6) 2016.According to the complainant, during the procedure, a calculus was captured with the trapezoid basket in the common bile duct.However, the handle broke while attempting to withdraw the calculus.A different basket was used to remove the calculus from the trapezoid basket and to complete the procedure.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: 6184794
• MDR Text Key: 62672883
• Report Number: 3005099803-2016-03905
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)20170714(10)19477755
• 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: 12/05/2016

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: 07/14/2017
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 19477755
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/15/2016
• 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): Required Intervention