MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC TRAPEZOID RX

Model Number 08714729296393

Device Problems Sticking (1597); Device Operates Differently Than Expected (2913)

Patient Problems Pain (1994); Device Embedded In Tissue or Plaque (3165)

Event Date 07/09/2017

Event Type  Injury  

Event Description

Pt went to operating room for ercp with preop diagnosis of cholelithiasis and common bile duct stone.During the procedure the stone and the trapezoid (wire guided retrieval basket) became stuck in the pt's body as the fail safe device did not deploy.Physician was unable to remove the stone and the basket retrieval out of the pt.So a surgeon was called and a cholecytectomy, cholangiogram and common bile duct exploration with removal of retrieval device and placement of stent was performed.Current status of pt: pt is now 3 days post op and remains hospitalized.He is recovering from his surgical intervention.Drainage in jp drains is diminishing in quantity.His preop lab abnormalities are continuing to improve.He appears to be stable.Pt.Is on clear liquids and pain is easing up.Pt.Will remain on clear liquids at least 24 more hours.

• Brand Name: BOSTON SCIENTIFIC TRAPEZOID RX
• Type of Device: TRAPEZOID RX
• Manufacturer (Section D): BOSTON SCIENTIFIC; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6756455
• MDR Text Key: 81610039
• Report Number: MW5071303
• Device Sequence Number: 1
• Product Code: LQC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/12/2017

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: 09/27/2017
• Device Model Number: 08714729296393
• Device Catalogue Number: M00510880
• Device Lot Number: 19771228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/28/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 80