MAUDE Adverse Event Report: BOSTON SCIENTIFIC FLEXIMA URETERAL STENT, STRETCH VL

Model Number 08714729160809

Device Problems Break (1069); Detachment Of Device Component (1104); Material Separation (1562)

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

Event Date 05/03/2016

Event Type  Injury  

Event Description

While retracting wire, plastic piece broke at wire insertion point and separated from catheter.Was not left in patient.

• Brand Name: FLEXIMA URETERAL STENT, STRETCH VL
• Type of Device: FLEXIMA URETERAL STENT
• Manufacturer (Section D): BOSTON SCIENTIFIC
• MDR Report Key: 5662230
• MDR Text Key: 45485621
• Report Number: MW5062326
• Device Sequence Number: 1
• Product Code: FFA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/05/2019
• Device Model Number: 08714729160809
• Device Catalogue Number: M0061851560
• Device Lot Number: 18766914
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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: 71 YR