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

Model Number 2914001005

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

Patient Problems Abdominal Pain (1685); Diarrhea (1811); Ischemia (1942); Vomiting (2144)

Event Date 09/15/2022

Event Type  Injury  

Event Description

According to the available information, coloplast was notified of the incident that occurred after use of the peristeen plus transanal irrigation system.It was reported that on (b)(6) 2022 the user performed regular procedure with use of the device without any issues.Evacuation started and then suddenly stopped.The user felt a major (¿huge¿) pain.The user went to bed without eating, the pain continued, she vomited and in the evening, she went to the hospital ((b)(6)).The morning after she was hospitalized and operated on.According to the available information, the patient did not sustain perforation.No further information is available at this time.

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.

Manufacturer Narrative

Medical assessment has been added to the "report incident description" field."report incident description field" has been updated.

Event Description

According to the information available, this case concerns a 45-year-old woman suffering from cauda equina and multiple sclerosis, which over time prompted a neurogenic bladder and bowel.In 1996 she had a right sided adnexectomy.The patient irrigated since 2005 (enemas) every 2nd day, using peristeen since 2011 without essential problems, apart from ¿incomplete evacuation¿.On the day of the incident the patient irrigated as normal when the evacuation procedure suddenly stopped and strong abdominal pain developed.At the emergency department a mechanical adherence ileus (string ileus) at the site of the previous surgery was diagnosed and confirmed at the subsequent laparoscopy.The affected 30 cm long lieal segment, located 40 cm from the ileocecal valve, was resected, and a vital anastomosis established.Eventless recovery, the patient was discharged from hospital day 7.No further information was provided.

Manufacturer Narrative

After further evaluation, it has been justified that based on the medical assessment, this incident was not device related.A causal relationship between peristeen transanal irrigation and a mechanical ileus of an ileal segment in the right iliac fossa is unlikely and the incident is considered as coincidental.Therefore, this incident is no longer considered reportable.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• 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: 16077756
• MDR Text Key: 306424793
• Report Number: 3006606901-2022-00024
• 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: Consumer
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 02/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2914001005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/05/2022
• 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; Required Intervention; Life Threatening
• Patient Age: 45 YR
• Patient Sex: Female
• Patient Weight: 60 KG