MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE

Catalog Number 482151

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Apnea (1720); Asthma (1726); Diarrhea (1811); Pain (1994); Urinary Retention (2119); Discomfort (2330); Prolapse (2475); Dyspareunia (4505); Urinary Incontinence (4572); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

The patient's attorney alleged a deficiency against the device.Additional information has been requested, but not yet received.Per additional information received via medical records on (b)(6) 2022, the patient has experienced pelvic pain, urgency and leakage, incontinence, overactive bladder, irritable bowel syndrome, dyspareunia, obesity, recurrent vaginal pain, urinary retention, uterine prolapse, chronic tonsillitis, stage 2 anterior vaginal wall prolapse, bladder hypertonicity, lower urinary tract symptoms, pelvic floor dysfunction, diarrhea, hemorrhoids, obstructive sleep apnea., incomplete bladder emptying, asthma and required additional surgical and non-surgical interventions.

Manufacturer Narrative

The reported event could not be confirmed.No sample was returned for evaluation.Based on the investigation findings, current manufacturing controls are considered adequate as to detect and segregate any non-conforming unit.Event described could not be confirmed as a manufacturing related issue.The alleged event is most likely associated with possible procedural/surgical complications.The ifu currently addresses potential risks associated with surgically implantable materials.Precautions: the usual precautions associated with urological procedures, specifically cystoscopy, should be followed.The pelvilace¿ to system is for single-patient use only and is to be implanted surgically.Postoperative retropubic bleeding may occur in some patients and must be controlled before patient release.The pelvicol® sling in the pelvilace¿ to system should be moist when removed from the packaging.Do not implant the pelvicol® sling if it is dehydrated or dry.The pelvilace¿ to system procedure requires diligent attention to anatomical structure and care to avoid puncture of large vessels, nerves, bladder, and bowel, during needle passage.Proper placement of the pelvilace¿ to system at mid-urethra requires that the tissue sling lie flat with minimal or no tension under the urethra.The pelvilace¿ to system is intended as a single-use, disposable device.Do not resterilize any portion of the pelvilace¿ to system.Patients should be advised that pregnancy following a pelvilace¿ to system procedure may negatively affect the success of the previous procedure and incontinence may reoccur.The safety and effectiveness of pelvilace¿ to system has not been established for the treatment of stress urinary incontinence in males and children under the age of 18.Do not use the pelvilace¿ to system if the integrity of the packaging appears compromised.Adverse events: potential complications associated with the proper implantation of the pelvilace¿ to system may include, but are not limited to: postoperative hematoma, which may occur following the implant procedure.Temporary urinary retention, bladder outlet obstruction, and voiding difficulties associated with over-correction/too much tension placed on the implant perforations or lacerations of vessels, nerves, bladder or bowel, which may occur during needle passage transitory irritation at the operative wound site, which may elicit a foreign body response that leads to inflammation, infection, or erosion at the implant site.(b)(4).

• Brand Name: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Type of Device: PELVILACE® TO TRANS-OBTURATOR BIOURETHRAL SUPPORT SYSTEM WITH HOOK NEEDLE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 15428679
• MDR Text Key: 299973852
• Report Number: 1018233-2022-90031
• Device Sequence Number: 1
• Product Code: PAG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K042949
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/14/2022

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
• Device Expiration Date: 04/30/2013
• Device Catalogue Number: 482151
• Device Lot Number: BMVA0004
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Initial Date Manufacturer Received: 08/25/2022
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/21/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 33 YR
• Patient Sex: Female
• Patient Weight: 83 KG
• Patient Race: White