MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION RESCUENET¿; SNARE, FLEXIBLE

Model Number DGN-538

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 11/19/2019

Event Type  malfunction  

Event Description

Patient presented to emergency room with complaint of feeling of food stuck in esophagus.Pt underwent endoscopic procedure to remove foreign body.Per the manager of the unit, during an esophageal foreign body removal, the basket shredded off the probe after one use.Four in total were used, all devices failed prematurely.

• Brand Name: RESCUENET¿
• Type of Device: SNARE, FLEXIBLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 9488579
• MDR Text Key: 171826770
• Report Number: 9488579
• Device Sequence Number: 1
• Product Code: FDI
• 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: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DGN-538
• Device Catalogue Number: DGN-538
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/02/2019
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13505 DA
• Patient Weight: 110