MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE

Model Number M006850701

Device Problems Break (1069); Defective Device (2588)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/14/2023

Event Type  malfunction  

Event Description

The surgeon attempted to place mid-urethral sling whereupon the barb of the sling broke off in the right side of the operative site of the patient.The barb was left in place in the patient and the remainder of the defective sling was removed from the sterile field and requisitioned.The surgeon then placed a new sling which worked effectively.

• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 16852884
• MDR Text Key: 314371529
• Report Number: 16852884
• Device Sequence Number: 1
• Product Code: PAH
• 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: 04/26/2023

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: M006850701
• Device Lot Number: 30500999
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/26/2023
• Event Location: Ambulatory Surgical Facility
• Date Report to Manufacturer: 05/02/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/02/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1