MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN PLUS TRANSANAL IRRIGATION WITH BALLOON CATHETERS - SYSTEM AND ACCESSOR; MANUAL RECTAL IRRIGATION SYSTEM

Catalog Number 29140/291400

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bowel Perforation (2668)

Event Date 12/04/2023

Event Type  Injury  

Manufacturer Narrative

H3 other text : device not returned to manufacturer.

Event Description

This case concerns a 61 year-old male patient who due to rectal cancer, had a low anterior resection (end to side anastomosis) in 2022 with closure of ileostomy in (b)(6) 2023.Patient had neoadjuvant radio-chemotherapy.No further medical history described.Due to major lars with incontinence, tai with peristeen (regular catheter) with 300-400 ml of water was successfully initiated (b)(6) 2023 for every day the first 5 days and every second day afterwards.Training was performed at the hospital.On (b)(6) 2023, the patient performed a tai procedure with normal/eventless insertion of the catheter, 1 pump of the balloon, instillation of around 350 ml of water, normal/eventless removal of the catheter and bowel emptying as a result of the irrigation.After the procedure abdominal pain and fever started to appear and the patient was admitted to the hospital around 12-18 hours later.The patient was hospitalized for 18 days after the incident.Scanning (ct) confirmed a perforation, which is described as an intraperitoneal punctate perforation, 5-6 cm from anus likely near the anastomosis (no further details).The patient was treated conservatively (fasting, infusion therapy, antibiotics) and had an uneventful recovery.After 12 days of peristeen irrigation, this lars patient with a side to end anastomosis experienced an intraperitoneal bowel perforation near the anastomosis.Patient was treated conservatively and recovered.

• Brand Name: PERISTEEN PLUS TRANSANAL IRRIGATION WITH BALLOON CATHETERS - SYSTEM AND ACCESSOR
• Type of Device: MANUAL RECTAL IRRIGATION SYSTEM
• Manufacturer (Section D): COLOPLAST A/S; 1 holtedam humlebaek, dk 3050; humlebaek 3050 ; DA 3050
• Manufacturer Contact: usgab giovanna abugre ; 1601 west river road n; minneapolis, MN 55411
• MDR Report Key: 18567068
• MDR Text Key: 333520717
• Report Number: 3006606901-2024-00002
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K083770
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 29140/291400
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No
• 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; Life Threatening
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 85 KG