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

Model Number M00510890

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/07/2015

Event Type  malfunction  

Manufacturer Narrative

(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) on (b)(6) 2015.According to the complainant, during the procedure, the side car-rx push back.The procedure was completed with another of the same device.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 "fine.".

Manufacturer Narrative

A visual examination of the device found the basket to be retracted/ closed.The side car-rx presented pushback out of specification.Further evaluation revealed that the side car-rx was torn on both proximal and distal ends.The sheath was buckled adjacent to the heat shrink.The customer had removed the handle label.A functional evaluation was performed without any resistance.The evaluation concluded that the condition of the returned unit was consistent with the complaint incident that the device presented side car-rx pushback.Additionally, the side car-rx presented tearing.The sheath was buckled adjacent to the heat shrink.The side car-rx pushback could cause difficulty in tracking the device over the guidewire and into the papilla.Per the event info, the issue was noticed during the procedure and while inside the patient.Due to anatomical /procedural factors encountered during the procedure performance was limited.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed; no anomalies were noted.

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) on (b)(6) 2015.According to the complainant, during the procedure, the side car-rx push back.The procedure was completed with another of the same device.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 ¿fine.¿.

• 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: 5338157
• MDR Text Key: 34779828
• Report Number: 3005099803-2015-03709
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 09/30/2016
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18466863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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