MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST¿ ADJUSTABLE SINGLE INCISION SLING; ADJUST TRANS OBTURATOR TAPE FOR STRESS UNRINARY INCONTINENCE

Catalog Number BRD700SI

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Erosion (1750)

Event Type  Injury  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.

Event Description

It was reported that the vaginal mesh tape caused erosion through the vaginal epithelium and requires removal of the implant.This took place on (b)(6) 2019 and the patient received general anesthesia for the procedure.

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause of the reported event could be that the mesh was curled where it attached to anchor or tube mesh due to which the mesh rolled, resulting in erosion of the mesh through the vaginal epithelium and requiring removal of the implant.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿caution: federal (usa) law restricts this device to sale by or on the order of a physician.This product is intended for use only by physicians trained in the surgical procedures and techniques required for the treatment of female stress urinary incontinence and the implantation of nonabsorbable meshes.The physician is advised to consult the medical literature regarding techniques, complications, and hazards associated with the intended procedures.Description the ajust® adjustable single-incision sling system is a minimally invasive suburethral sling intended for the treatment of female stress urinary incontinence.The system consists of an adjustable polypropylene mesh sling with permanent, self-fixating, polypropylene anchors, an introducer, and a flexible stylet for advancing the sling lock after adjustment.The device is terminally sterilized by ethylene oxide.Refer to figure 1 below for a detailed depiction of the ajust® system components.Figure 1: detailed depiction of the ajust® system components indications for use the ajust® adjustable single-incision sling system is indicated for the treatment of female stress urinary incontinence resulting from urethral hypermobility and/or intrinsic sphincter deficiency.Contraindications the ajust® sling system is contraindicated for patients experiencing any of the following conditions: pregnancy, urinary tract infection, anticoagulant therapy, and/or infection in the operative field.Warnings the implant procedure and the instrumentation associated with the surgical placement of the ajust® sling system carry an inherent risk of infection and bleeding, as do similar urological procedures.The use of surgical staples, clips, screws, or other non-suture attachment mechanisms not supplied with the ajust® sling system can damage the implant.After use, the product and its packaging should be treated as a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable local, state, and federal laws and regulations." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.H3 other text : the device was not returned.

Event Description

It was reported that the vaginal mesh tape caused erosion through the vaginal epithelium and requires removal of the implant.This took place on 06jun2019 and the patient received general anesthesia for the procedure.

• Brand Name: AJUST¿ ADJUSTABLE SINGLE INCISION SLING
• Type of Device: ADJUST TRANS OBTURATOR TAPE FOR STRESS UNRINARY INCONTINENCE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8754471
• MDR Text Key: 149846227
• Report Number: 1018233-2019-03517
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 08/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: BRD700SI
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 07/02/2019
• Supplement Dates Manufacturer Received: 07/15/2019
• Supplement Dates FDA Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention