MAUDE Adverse Event Report: BOSTON SCIENTIFIC BOSTON SCIENTIFIC; FLEXIMA BILIARY STENT 7F X 5 CM

Lot Number 17465275

Device Problems Break (1069); Stretched (1601)

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

Event Date 03/17/2017

Event Type  Injury  

Event Description

Patient underwent ercp with biliary stent placement using olympus system.During attempted deployment of the stent the introducer stretched and broke.The stent would not initially deploy but eventually did deploy after manipulation.This did not result in any complication or harm to the patient.

• Brand Name: BOSTON SCIENTIFIC
• Type of Device: FLEXIMA BILIARY STENT 7F X 5 CM
• Manufacturer (Section D): BOSTON SCIENTIFIC; 300 boston scientific way; marlborough MA 01752 1234
• MDR Report Key: 6442293
• MDR Text Key: 71256053
• Report Number: MW5068718
• Device Sequence Number: 1
• Product Code: FAD
• 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: 03/27/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 17465275
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 89 YR
• Patient Weight: 45