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

Model Number M00510880

Device Problems Break (1069); Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/27/2015

Event Type  malfunction  

Manufacturer Narrative

The complainant was unable to report the lot number; therefore the manufacture date and expiration date are unknown.However, the complainant stated that the device was used prior to the expiration date.(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 a lithotripsy procedure performed on (b)(6) 2015.According to the complainant, a trapezoid rx basket was used to crush and remove stones in the common bile duct.The procedure was completed with this device with no issues.After the procedure, the physician removed the basket from the patient's body and tested the device by opening and closing the basket while loaded into the alliance handle; however, the handle cannula broke.No issues or anomalies was noted with the alliance handle.Additionally, the side car-rx presented pushback.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 "good.".

Manufacturer Narrative

A visual analysis of the returned device revealed the handle cannula was bent upward and broken from compressive force applied to the handle during use.The basket tip was detached and not returned.Further evaluation found the side car-rx torn at the distal end and presented pushback out of specification.It appears the device functioned as intended during the procedure and was used to crush and remove multiple stones.The broken handle cannula and detached tip were likely caused as the user applied excessive force to the handle assembly and the handle cannula was then forced upward until it failed and broke.Because the customer damaged the device after the successful procedure and outside the patient, the most probable root cause for this complaint is handling damage.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx basket was used in the common bile duct during a lithotripsy procedure performed on (b)(6) 2015.According to the complainant, a trapezoid¿ rx basket was used to crush and remove stones in the common bile duct.The procedure was completed with this device with no issues.After the procedure, the physician removed the basket from the patient's body and tested the device by opening and closing the basket while loaded into the alliance handle; however, the handle cannula broke.No issues or anomalies was noted with the alliance handle.Additionally, the side car-rx presented pushback.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 "good.".

• 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: 5323218
• MDR Text Key: 34276990
• Report Number: 3005099803-2015-03655
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• 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: 11/30/2015

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 Model Number: M00510880
• Device Catalogue Number: 1088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/30/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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