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

Model Number M00510890

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  Injury  

Manufacturer Narrative

According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.

Event Description

It was reported to boston scientific corporation that a trapezoid¿ rx was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) lithotripsy procedure performed on (b)(6) 2016.According to the complainant, during the procedure while attempting to crush a stone, the trapezoid¿ rx basket failed to crush the entrapped stone.The tip of the basket was intentionally disengaged, following the directions for use, in order to release the entrapped stone and remove the basket from the patient.According to the physician, the tip was not able to pass naturally and was ¿penetrated under mucosa¿ remaining inside the patient.An additional procedure was performed using a spyglass ds in order to locate and remove the detached tip.Although the tip was located using radioscopic vision, it could not be seen endoscopically.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 ¿ok¿.

• 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: 6140424
• MDR Text Key: 61291000
• Report Number: 3005099803-2016-03740
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296409
• UDI-Public: (01)08714729296409(17)20170209(10)18909011
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K040447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/11/2016

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: 02/09/2017
• Device Model Number: M00510890
• Device Catalogue Number: 1089
• Device Lot Number: 18909011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2016
• Initial Date FDA Received: 12/01/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2016
• 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