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

Model Number M00510870

Device Problem Separation Failure (2547)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2018

Event Type  Injury  

Manufacturer Narrative

(b)(4).According to the complainant, the suspect device 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 basket was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2018.According to the complainant, during procedure, the basket failed to crush and the tip failed to detached.An alliance handle was then used in conjunction with the trapezoid¿ basket to detach the tip.However, the tip remained inside the patient.The patient was then sent to another facility for the removal of the tip.

• 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: 7636622
• MDR Text Key: 112270300
• Report Number: 3005099803-2018-02036
• Device Sequence Number: 1
• Product Code: LQC
• UDI-Device Identifier: 08714729296386
• UDI-Public: 08714729296386
• 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,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2018

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: 06/14/2018
• Device Model Number: M00510870
• Device Catalogue Number: 1087
• Device Lot Number: 20767848
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/04/2018
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/16/2017
• 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