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

Model Number M00617526300

Device Problems Material Fragmentation (1261); Defective Device (2588)

Patient Problem Insufficient Information (4580)

Event Date 09/02/2021

Event Type  malfunction  

Event Description

Elderly female who presented with a right hydronephrosis and underwent right ureteral stent placement.At the conclusion of the case, notified by or team of stent fragment on back table with concern for placement of defective stent and possible sub-optimal bladder coil.Recommended proceeding with stent exchange now to minimize risks of stent migration in the event of incomplete bladder coil.

• Brand Name: PERCUFLEX PLUS
• Type of Device: STENT, URETERAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12582914
• MDR Text Key: 274946004
• Report Number: 12582914
• Device Sequence Number: 1
• Product Code: FAD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/28/2021,09/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00617526300
• Device Lot Number: 27539064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2021
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/28/2021
• Event Location: Hospital
• Date Report to Manufacturer: 10/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25915 DA
• Patient Weight: 117