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

Catalog Number	29152
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Bowel Perforation (2668)
Date of Event	08/26/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : device not returned to manufacturer.
Event or Problem Description
According to the available information, this case concerns a 70-year-old male patient with a medical history of a spinal cord injury at t1.Due to incontinence tai with peristeen was initiated approximately 4-5 years ago using 800-1000 ml of water, daily and with 3 pumps of the balloon.The patients used around 1.5 hours for the procedure and still experienced weekly problems and varied stool consistency and varied sit time (from instant results to long periods of waiting).On (b)(6) 2023, the patient performed a tai procedure with normal insertion of the catheter and at least 3 pumps of the balloon.The balloon was not staying in place and there was leakage, which led to the patient using his fingers to hold or reposition the balloon.The patient did not experience pain (probably because of the underlying condition), but noticed blood, which he was used to with irrigations due to hemorrhoids.However, the bleeding continued, and the patient called a md and the following day the patient was hospitalized.It was reported (not specified how assessed) that the patient had an intraperitoneal rectal perforation with large hematoma near the rectosigmoid mesentery.The patient had surgery with a formation of a stoma (not further specified other than surgery x3).The patient was still admitted with a total of 26 days and recovering at reporting of the incident but was expected to be sent home (b)(6).No further information is available at this time.

• Brand Name: PERISTEEN PLUS TRANSANAL IRRIGATION WITH BALLOON CATHETERS - SYSTEM AND ACCESSOR
• Common Device Name: 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: 17916408
• Report Number: 3006606901-2023-00016
• Device Sequence Number: 6782046
• Product Code: KNT
• UDI-Device Identifier: 05708932732642
• UDI-Public: 05708932732642
• Combination Product (Y/N): N
• PMA/510(K) Number: K083770
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/11/2023

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 29152
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Life Threatening
• Patient Age: 70 YR
• Patient Sex: Male