MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BOSTON SCIENTIFIC LYNX BLUE SYSTEM SUPRAPUBIC MID-URETHRAL SLING; MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR

Model Number LYNX BLUE SYSTEM SUPRAPUBIC

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/06/2022

Event Type  malfunction  

Event Description

Lynx blue (suprapubic mid-urethral sling) system from boston scientific -was opened during surgery, the "end fell off of it" and another lynx system needed to be used.It was not implanted in the patient and no patient harm occurred.Fda safety report id# (b)(4).

• Brand Name: BOSTON SCIENTIFIC LYNX BLUE SYSTEM SUPRAPUBIC MID-URETHRAL SLING
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; marlborough MA 01752
• MDR Report Key: 15085932
• MDR Text Key: 296572236
• Report Number: MW5111066
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 0871472961932
• UDI-Public: (01)0871472961932(17)241005(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: LYNX BLUE SYSTEM SUPRAPUBIC
• Device Catalogue Number: M0068503010
• Device Lot Number: 28151024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 78 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White