MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION OBTRYX¿ SYSTEM - CURVED; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC,

Model Number M0068504000

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/30/2022

Event Type  malfunction  

Event Description

While surgeon inserting obtryx curved transobturator mid-urethral sling, the equipment malfunctioned.The blue plastic end piece used for insertion was dislodged in patient and could not be retrieved.Radiologist was contacted and assisted with c arm in attempting to retrieve foreign body.They were unsuccessful and patient was transferred to post-anesthesia care unit (pacu).Doctor notified interventional radiology.Device representative was notified.

• Brand Name: OBTRYX¿ SYSTEM - CURVED
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC,
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 15073326
• MDR Text Key: 296304311
• Report Number: 15073326
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/15/2022,07/12/2022

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 Model Number: M0068504000
• Device Catalogue Number: M0068504000
• Device Lot Number: 28231565
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/15/2022
• Date Report to Manufacturer: 07/21/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/21/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16790 DA
• Patient Sex: Female