MAUDE Adverse Event Report: COLOPLAST A/S ALTIS SINGLE INCISION SLING SYSTEM; FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER

Catalog Number 519650

Device Problem Difficult or Delayed Positioning (1157)

Patient Problem Perforation (2001)

Event Date 08/04/2023

Event Type  Injury  

Event Description

According to available information, this device required explantation due to a urethral tear.The doctor had some difficulty placing the anchor on the patient's left side.The first two attempts did not seat into the obturator membrane.The third attempt was successful.On the doctor's first or second attempts she missed the obturator and likely put the anchor into the urethra near the bladder neck.This caused the damage.The anchor pulled out upon device tensioning.A cystoscopy revealed no damage or device in bladder or urethra.The doctor did a crede maneuver and noticed saline leaking from the incision.A second cystoscopy revealed a small tear in patient's proximal left side of her urethra.Through the tear, the doctor was able to visualize the device.A second doctor was called and he advised the operating doctor to remove the device and to repair the urethral tear.

Manufacturer Narrative

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: ALTIS SINGLE INCISION SLING SYSTEM
• Type of Device: FEMALE STRESS URINARY INCONTINENCE SURGICAL MESH-SLING, SYNTHETIC POLYMER
• Manufacturer (Section D): COLOPLAST A/S; 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: 17650813
• MDR Text Key: 322286984
• Report Number: 2125050-2023-01065
• Device Sequence Number: 1
• Product Code: PAH
• Combination Product (y/n): N
• PMA/PMN Number: K121562
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/30/2023

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?: No
• Device Catalogue Number: 519650
• Device Lot Number: 8921905_5196502400
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/30/2023
• Date Device Manufactured: 01/26/2023
• 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: 41 YR