MAUDE Adverse Event Report: ABISS - ANALYTIC BIOSURGICAL SOLUTIONS ARIS TRANSOBTURATOR SYSTEM; SUTURE/NEEDLE PASSER, SINGLE-USE

Catalog Number 93-4400

Device Problem Device Appears to Trigger Rejection (1524)

Patient Problems Erosion (1750); Incontinence (1928); Inflammation (1932); Pain (1994); Urinary Retention (2119); Urinary Tract Infection (2120); Abnormal Vaginal Discharge (2123); Prolapse (2475); Dyspareunia (4505)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced incontinence, lower abdominal pain, recurrent urinary tract infections, painful intercourse, emotional problems, yellow vaginal discharge, hypermobile urethra, stress urinary incontinence, urinary leakage with movement, straining, incomplete bladder emptying, device erosion, cystocele, midline, rectocele, possible urethral stenosis and obstruction, and chronic stricture of female urethra.The patient stated that she and her husband separated because of her inability to have intercourse.Patient had explantation of her device under general anesthesia.Findings include palpable device with downward traction causing urethral kinking.Pathology report notes multinucleated giant cell reaction to device and chronic inflammation.Patient had a mid-urethral device implanted from another manufacturer, iliococcygeal suspension, anterior & posterior colporrhaphy with enterocele repair, vaginal approach and cystourethroscopy under general anesthesia.

Manufacturer Narrative

Coloplast has not been provided any corroborating evidence to verify the information contained in this report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

• Brand Name: ARIS TRANSOBTURATOR SYSTEM
• Type of Device: SUTURE/NEEDLE PASSER, SINGLE-USE
• Manufacturer (Section D): ABISS - ANALYTIC BIOSURGICAL SOLUTIONS; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usbes brian schmidt ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 17775765
• MDR Text Key: 323757552
• Report Number: 2125050-2023-01147
• Device Sequence Number: 1
• Product Code: OTN
• Combination Product (y/n): N
• PMA/PMN Number: K050148
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/19/2023

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 Expiration Date: 09/30/2018
• Device Catalogue Number: 93-4400
• Device Lot Number: 4085010_5195512400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Date Device Manufactured: 04/29/2014
• 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: 69 YR