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 Abscess (1690); Erosion (1750); Unspecified Infection (1930); Pain (1994); Abnormal Vaginal Discharge (2123); Vesicovaginal Fistula (4512)

Event Type  Injury  

Event Description

As reported to coloplast, though not verified, legal representative stated the patient with this device experienced device exposure, right groin abscess, right thigh abscess, yellowish discharge from posterior fornix, os slit from center to left, fistulogram, vaginal fistula, cutaneous fistula, perianal abscess, right lower limb abscess, chronic right groin wound, persistent purulent drainage from right groin wound, implantation of another manufacturer's device, two separate areas of device exposure on the right fornix - a distal area of device exposure measured about 1.5 cm and the second area measured about 0.5 cm just proximal to the first.Patient had a computer tomography guided percutaneous drainage of the abscess on her right side of her groin.Patient had another incision and drainage of a left leg abscess.Patient reported the abscess is not improving and feels a stiff nodule, right inner thigh 8 x 5 cm palpable mass tender to touch.Another incision and drainage of the right leg abscess.Patient was admitted for recurrent right groin abscess.Home health treatment was required for the abscess.Patient had right groin wound exploration with incision and drainage of abscess.Patient had another excision of the chronic right groin wound with layered closure, pathology notes fistula tract.Patient had excisional debridement of the right inguinal and thigh wound to the level of the muscle, cystoscopy, vaginoscopy and exam under general anesthesia.Patient had closure of the anterior vaginal wound and obliteration of the right vaginal fistula tract with rotation of a proximally based and partially deepithelialized vaginal mucosal flap, excisional debridement of the right inguinal wound and closure with local tissue rearrangement (the wound measuring 18 cm x 2.5 cm); vaginal device explantation and cystoscopy under general anesthesia.Patient had intra-operative cultures growing pseudomonas, right inguinal and medial thigh swollen and slightly erythematous, painful with compression and continued groin infection with resistant pseudomonas.

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: 17777556
• MDR Text Key: 323784692
• Report Number: 2125050-2023-01148
• 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: Consumer
• 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: 08/31/2013
• Device Catalogue Number: 93-4400
• Device Lot Number: 1911108_5195511400
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/19/2023
• Date Device Manufactured: 03/27/2009
• 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: 55 YR