MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 ALIGN® TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HALO; ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO

Model Number BRD500HL

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Keratitis (1944); Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation.A potential root cause for this failure could be "physician does perform cystoscopy or rectum exam to try to save time; physician is not properly trained".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: ¿precautions 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 align® to urethral support 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 align® to urethral support system is intended as a single-use device.Do not re-sterilize any portion of the align® to urethral support 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 align® to urethral support system implant procedure has not been established for the treatment of stress urinary incontinence in males and 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 align® to urethral support system if the packaging is opened or damaged.As for any implantable material, it is recommended to open the package at the time of implantation.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 align® to urethral support 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,¿.The user guide currently contains instruction that would assist in preventing potential user related causes of reported issue." the user guide currently contains instruction that would assist in preventing potential user related causes of reported issue.".

Event Description

It was reported that the patient experienced pain in the lower belly on each side of the groin, the inner muscles of the thighs, and from their knees to their ankles following the implantation of the mesh on (b)(6) 2010.The patient was unable to walk for very long or perform activities.The patient alleged that the symptoms started (b)(6) 2011.

• Brand Name: ALIGN® TO TRANS-OBTURATOR URETHRAL SUPPORT SYSTEM - HALO
• Type of Device: ALIGN® TO URETHRAL SUPPORT SYSTEM - HALO
• 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: yonic anderson ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 9247468
• MDR Text Key: 165962200
• Report Number: 1018233-2019-06852
• Device Sequence Number: 1
• Product Code: OTN
• UDI-Device Identifier: 00801741016226
• UDI-Public: (01)00801741016226
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K093747
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 10/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2012
• Device Model Number: BRD500HL
• Device Catalogue Number: BRD500HL
• Device Lot Number: HUUF2521
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/23/2010
• 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): Other