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

Model Number M00510890

Device Problem Detachment Of Device Component (1104)

Patient Problems Perforation (2001); No Known Impact Or Consequence To Patient (2692)

Event Date 08/11/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Patient's exact age is unknown; however it was reported that the patient was under the age of 18.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.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the bile duct during a procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when withdrawing the device from the bile duct, the basket detached and remained inside the patient.The basket was scheduled for removal within 4-6 weeks from the date of the procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental mdr will be submitted.

Manufacturer Narrative

Visual evaluation of the returned device found the side car-rx was torn and presented pushback out of specification.Further evaluation found the pull wire was kinked and broken.The remaining part of the pull wire with basket was not returned.During the procedure, manipulation of the device and interaction with the scope or other devices could have contributed to the failures of side car-rx pushback and torn, and pull wire kinked.It cannot be determined precisely how the pull wire failed.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.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 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 bile duct during a procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when withdrawing the device from the bile duct, the basket detached and remained inside the patient.The basket was scheduled for removal within 4-6 weeks from the date of the procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental mdr will be submitted.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the bile duct during a procedure performed on (b)(6) 2016.According to the complainant, during the procedure, when withdrawing the device from the bile duct, the basket detached and remained inside the patient.The basket was scheduled for removal within 4-6 weeks from the date of the procedure.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available, a supplemental mdr will be submitted.Additional information received as of 13dec2016: the patient had returned five months after the event to have the detached basket removed, instead of 1 month later.During the removal procedure, the rigid shaft was noticed to have perforated the intestine and the other extremity was stuck into the pericardium.The detached basket with captured stone was successfully removed from the patient.

• 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: 5962042
• MDR Text Key: 55096608
• Report Number: 3005099803-2016-02837
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 08/24/2016

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: 10/18/2016
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18528481
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/24/2016
• Initial Date FDA Received: 09/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/10/2016; 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/20/2015
• 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