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

Model Number M0068503010

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/09/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported to boston scientific corporation that a lynx blue system device was used during a sling procedure performed on (b)(6) 2020.According to the complainant, part of the plastic sleeve detached during the procedure.The detached piece did not fall off into the patient.The procedure was completed with another lynx blue system device.There were no patient complications reported as a result of the event.

Manufacturer Narrative

Block h6: device code 2907 captures the reportable event of sleeve detachment.Block h10: the mesh sleeve was returned without the mesh or the delivery devices.A visual examination of the returned sleeve revealed that it was cut in two.The association loops were present on both ends of the sleeve and there was no evidence that there were pieces missing.Returned product analysis was unable to identify any issue with the returned components.Therefore, the complaint could not be confirmed.A review of the device history record (dhr) confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.Based on the investigation results, the most probable cause chosen for this complaint is no problem detected as there was no evidence found to suggest an issue with the device.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.

Event Description

It was reported to boston scientific corporation that a lynx blue system device was used during a sling procedure performed on (b)(6), 2020.According to the complainant, part of the plastic sleeve detached during the procedure.The detached piece did not fall off into the patient.The procedure was completed with another lynx blue system device.There were no patient complications reported as a result of the event.

• Brand Name: LYNX BLUE SYSTEM
• Type of Device: MESH, SURGICAL, SYNTHETIC, UROGYNECOLOGIC, FOR STRESS URINARY INCONTINENCE, RETR
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10815519
• MDR Text Key: 215501703
• Report Number: 3005099803-2020-05040
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 08714729961932
• UDI-Public: 08714729961932
• Combination Product (y/n): N
• PMA/PMN Number: K020110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/04/2021

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 Operator: Health Professional
• Device Expiration Date: 03/19/2023
• Device Model Number: M0068503010
• Device Catalogue Number: 73193
• Device Lot Number: 0025376844
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2020
• Initial Date Manufacturer Received: 10/12/2020
• Initial Date FDA Received: 11/10/2020
• Supplement Dates Manufacturer Received: 12/08/2020
• Supplement Dates FDA Received: 01/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1