MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN PLUS TRANSANAL IRRIGATION SYSTEM; PERISTEEN PLUS SYSTEM R. - T.B

Model Number 2914001732

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

Patient Problem Bowel Perforation (2668)

Event Type  Injury  

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.

Event Description

According to available information, this case concerns a 20-year-old male with spina bifida (complete paralysis of both lower limbs and decreased rectal and anal sensation).Before initiation of peristeen irrigation, the users mother irrigated using a stoma irrigation set.Mid-october 2022 the irrigation set was changed to peristeen (adult catheter) and the user took over the procedure in the subsequent 2,5 months, without any problems being mentioned.Irrigation was performed with 300 ml water twice weekly.On january 2nd, the user experienced a heavy bleed and abdominal pain immediately after removing the catheter.Due to development of fever, he was hospitalised, and a ct-scan disclosed a perforation (air in retroperitoneum but not in the abdominal cavity).The subsequent laparotomy revealed a punctate perforation (penetration) of the sigmoid, which was resected, and an end-stoma created.The user recovered quickly with concomitant antibiotic coverage.Expert physicians discussed the case and concluded that because the evacuation started while the catheter was still in situ, the bowel wall was sucked into the catheter hole (invagination) and prompted the perforation into mesocolon (extraperitoneal).No further information is available.

• Brand Name: PERISTEEN PLUS TRANSANAL IRRIGATION SYSTEM
• Type of Device: PERISTEEN PLUS SYSTEM R. - T.B
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST HUNGARY - NYI; coloplast utca 2; nyírbátor 4300 ; HU 4300
• Manufacturer Contact: usmaco maria bosse ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 16292778
• MDR Text Key: 308735344
• Report Number: 3006606901-2023-00004
• Device Sequence Number: 1
• Product Code: KNT
• Combination Product (y/n): N
• PMA/PMN Number: K140310
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/03/2023

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 Operator: Lay User/Patient
• Device Model Number: 2914001732
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2023
• Initial Date FDA Received: 02/03/2023
• 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): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 20 YR
• Patient Sex: Male