LYNX SYSTEM MESH SLING, BLADDER SLING

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-16 for LYNX SYSTEM MESH SLING, BLADDER SLING manufactured by Boston Scientific Corp..

Event Text Entries

[124461054] Initial surgery date (b)(6) 2018 product issue discovered (b)(6) 2018 product: lynx system mesh sling. Procedure: total vaginal hysterectomy, bilateral salpingo-oophorectomy, anterior repair, posterior repair, tension-free vaginal tape placement for mid-urethral sling, cystoscopy. The sling is manufactured with a clear sheath that is to be removed during the procedure; however, the sheath is not marketed that it must be removed. The sling sheath is clear, so it is not visibly evident when the removal step be bypassed for any reason. During the above procedure, the sling sheath was inadvertently left in place bilaterally. On the pt's post op visit, on (b)(6) 2018 her vaginal exam revealed a retained sling sheath in her right posterior vaginal fornix. The pt required surgical removal of the retained sheath on (b)(6) 2018. On her post op visit for that second surgery ((b)(6) 2018). It was discovered that the left sling sheath had also been retained and was visible on the left side underneath mid urethra. It was not evident at the earlier exam as it had not eroded through the tissues. This sheath was able to be removed by pulling gently, so a third surgery was not necessary.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW5080611
• MDR Report Key: 7973561
• Date Received: 2018-10-16
• Date of Report: 2018-10-12
• Date of Event: 2018-05-24
• Date Added to Maude: 2018-10-17
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: LYNX SYSTEM MESH SLING, BLADDER SLING
• Generic Name: INSTRUMENTATION, SURGICAL MESH, UROGYNECOLOGIC STRESS URINARY INCONTINENCE
• Product Code: PWI
• Date Received: 2018-10-16
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: BOSTON SCIENTIFIC CORP.

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Hospitalization; 2. Required No Informationntervention	2018-10-16