MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN AVAULTA - BARD; UNKNOWN AVAULTA SUPPORT SYSTEM

Device Problems Patient-Device Incompatibility (2682); Material Protrusion/Extrusion (2979)

Patient Problems Erosion (1750); Micturition Urgency (1871); Necrosis (1971); Pain (1994)

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 patient experienced urinary urgency, urinary frequency, suprapubic pain, and recurrent urinary tract infections.The patient subsequently underwent placement of a sacral neurostimulator for presumed refractory overactive bladder.A cystoscopy revealed a 2-cm mesh extrusion in the posterior bladder wall near the right ureteral orifice.A cystoscopy operation was performed to suture and remove the extruded mesh.The mesh fibers were then trimmed until no fibers were seen.An additional cystoscopy was performed three months later and necrotic debris was found.The patient's symptoms had completely resolved other than mild urinary urgency.

Manufacturer Narrative

The device was not returned for evaluation.The lot number is unknown; therefore, the device history record could not be reviewed.Although the product family is unknown, the unknown avaulta - bard product ifus are found to be adequate based on past reviews.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.

Event Description

It was reported that the patient allegedly experienced urinary urgency, urinary frequency, suprapubic pain, and recurrent urinary tract infections.The patient subsequently underwent placement of a sacral neurostimulator for presumed refractory overactive bladder.A cystoscopy revealed a 2-cm mesh extrusion in the posterior bladder wall near the right ureteral orifice.A cystoscopy operation was performed to suture and remove the extruded mesh.The mesh fibers were then trimmed until no fibers were seen.An additional cystoscopy was performed three months later and necrotic debris was found.The patient's symptoms had completely resolved other than mild urinary urgency.

• Brand Name: UNKNOWN AVAULTA - BARD
• Type of Device: UNKNOWN AVAULTA SUPPORT SYSTEM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8235108
• MDR Text Key: 132768501
• Report Number: 1018233-2019-00215
• Device Sequence Number: 1
• Product Code: OTP
• Combination Product (y/n): N
• PMA/PMN Number: K083839
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature,other
• Remedial Action: Notification
• Type of Report: Initial,Followup
• Report Date: 04/01/2019

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/18/2018
• Initial Date FDA Received: 01/10/2019
• Supplement Dates Manufacturer Received: 03/11/2019
• Supplement Dates FDA Received: 04/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 55 YR