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 10/16/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual evaluation of the device found the basket to be extended and wires folded.The basket was manually unfolded and basket was then found to open fully and wires were properly formed.Furthermore, the side car-rx presented pushback out of specification.According to the reported event, the issue occurred during the procedure and inside the patient.The complaint is associated with a product that meets the design and manufacture specifications but due to anatomical/procedure 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) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.A search of the complaint database confirmed that no similar complaints exist for the specified batch.

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 on (b)(6) 2015.According to the complainant, during the procedure, the customer attempted to open the basket but it did not open smoothly.The device was removed from the patient and another attempt to open the basket was made; however, the basket wires were found tangled.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 "good".This event has been deemed a reportable event based on the investigation results; side car-rx pushback.Please see report for full investigation details.

• 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: 5331508
• MDR Text Key: 34524518
• Report Number: 3005099803-2015-03697
• 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,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/02/2015

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 Expiration Date: 05/26/2016
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18032734
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/02/2015
• Initial Date FDA Received: 12/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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