MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION PERCUFLEX PLUS; STENT, URETERAL

Model Number 175264

Device Problems Entrapment of Device (1212); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 04/02/2022

Event Type  Injury  

Event Description

Radiographic marker on the end of the stent pusher came detached from the pusher and was detected on x-ray to be in the kidney, left behind in the pt during placement of the stent.Faint outline could be detected on the end of the stent pusher, where the radiographic marker was attached.Pusher did not appear to be broken or damaged, aside from the marker coming off.

• Brand Name: PERCUFLEX PLUS
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA
• MDR Report Key: 13506450
• MDR Text Key: 285477093
• Report Number: MW5107353
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/02/2022

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: 02/12/2024
• Device Model Number: 175264
• Device Catalogue Number: M0061752640
• Device Lot Number: 28495266
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male