MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 AJUST® ADJUSTABLE SINGLE-INCISION SLING

Catalog Number BRD700SI

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Granuloma (1876); Discomfort (2330)

Event Date 11/30/2023

Event Type  Injury  

Event Description

It was reported that the patient complained of a sensation of discomfort.The urologist removed the strip on 30nov2023.The biopsy result showed no cancerous cells but an inflammatory granuloma.Bacteriological results are pending.The strip in question was no longer in their possession.It was unknown what medical intervention was provided.As per the follow up information received on 11dec2023, as a result of discomfort, the patient underwent surgery and was hospitalized for removal of the strip.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all 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 complained of a sensation of discomfort.The urologist removed the strip on (b)(6) 2023.The biopsy result showed no cancerous cells but an inflammatory granuloma.Bacteriological results are pending.The strip in question was no longer in their possession.It was unknown what medical intervention was provided.As per the follow up information received on 11dec2023, as a result of discomfort, the patient underwent surgery and was hospitalized for removal of the strip.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be due to "material selection".The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "the usual precautions associated with urological procedures should be followed: based on physician experience and training, a thorough assessment of each patient should be made to determine their suitability for the implant procedure.Additional consideration should be given to use of the implant in patients with a compromised immune system, any condition that would compromise healing, or any patient with a history of prior abdominal or pelvic surgeries.Consideration should also be given to the ability of the patient to tolerate the surgical procedure.Accepted surgical practice and precautions must be followed for the management of contaminated or infected wound sites, when the ajust¿ sling system is used.Postoperative bleeding may occur in some patients and must be controlled prior to patient release.The implant procedure requires diligent attention to anatomical structures and care to avoid puncture of large vessels, nerves, bladder, bowel, urethra and any viscera, during introducer passage.Due to anatomical distortion that can be caused by pelvic organ prolapse, if the patient requires cystocele repair, it should be performed prior to the implantation of the sub-urethral sling.Proper placement of the sling implant at the mid-urethra requires that it lie flat with minimal or no tension under the urethra.The ajust¿ sling system is intended as a single-use device.Do not resterilize any portion of the ajust¿ sling system.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Patients should be advised that pregnancy following a sling implant procedure may negatively affect the success of the previous implant procedure and incontinence may recur.The safety and effectiveness of the ajust¿ sling system implant procedure has not been established for the treatment of stress urinary incontinence in males or children under the age of 18.Cystoscopy can be considered at the physician¿s discretion.Check the integrity of the packaging before use.Do not use the implant or introducers if the packaging is opened or damaged.As for any implantable material, it is recommended to open the package at the time of implantation.Upon opening the ajust¿ sling system tray, the components should be carefully transferred into the sterile field.The tray should not be inverted to remove components.Post-operatively the patient should be advised to refrain from heavy lifting, exercise (e.G.Cycling, jogging) and/or intercourse until the physician determines it is suitable for the patient to return to normal activities.Adverse events: complications associated with the proper implantation of the ajust¿ sling system may include, but are not limited to: postoperative hematoma, seroma, abscess or fistula formation, or scarring which may occur following the implant procedure.Urinary retention, bladder outlet obstruction and other voiding dysfunctions.These conditions may be associated with over-correction/too much tension placed on the implant.Perforations or lacerations of vessels, nerves, bladder, bowel, urethra, or any viscera, which may occur during the implantation procedure.Irritation at the operative wound site which may elicit a foreign body response that leads to wound dehiscence, inflammation and/or infection.Extrusion through vaginal epithelium or erosion into surrounding viscera and/or mucosa.Inflammation, sensitization, pain, dyspareunia, scarification, contraction, device migration and failure of the procedure resulting in recurrence of incontinence." h11: section a through f - the information provided by bd represents all 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.

• Brand Name: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Type of Device: AJUST® ADJUSTABLE SINGLE-INCISION SLING
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18418472
• MDR Text Key: 331597006
• Report Number: 1018233-2023-09348
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K092607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/11/2024

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: 10/01/2012
• Device Catalogue Number: BRD700SI
• Device Lot Number: HUVF0873
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/29/2023
• Supplement Dates Manufacturer Received: 01/11/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/06/2011
• 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): Hospitalization; Required Intervention
• Patient Sex: Female