MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; PERISTEEN ANAL IRRIG SYSTEM

Model Number	2912901400
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Abscess (1690); Sepsis (2067); Abdominal Distention (2601); Bowel Perforation (2668)
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the available information, coloplast was notified about an incident involving peristeen transanal irrigation system, resulting in bowel perforation.No additional details are available to date.
Additional Manufacturer Narrative
The necessary information was not available to date.Additional details and medical assessment are to be obtained and provided in the next report.Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Once our evaluation is complete, a follow-up report will be submitted.
Event or Problem Description
This report is based on limited information, even after repeated inquiries to family members and care-givers, concerning a 63-year-old male (bmi 31), who is a u.S.Resident, suffering from multiple sclerosis (ms) and multiple comorbidities (not described in detail).There is no information regarding medication or other medical history.Due to constipation, peristeen irrigation was initiated about 2 years prior to the present event, and the patient had at that time been rectally examined and trained to irrigate himself.The patient used 700-900 ml water and irrigated himself mostly every day (reported by wife).On the day of the event, it appears that the insertion of the catheter was eventless, but in the descriptions, it is mentioned that ¿he heard a ¿pop¿ and then felt unwell and fainted.He was immediately transferred to a hospital emergency room.A ct scan was performed, and it states in the descriptions that it showed a ¿thickening of the rectal-sigmoidal wall¿.An acute laparotomy was performed, and 700-900 ml was ¿evacuated from the abdominal cavity¿ with subsequent colostomy creation.The post-operative trajectory was complicated by sepsis and abscess formation and the patient was in antibiotic treatment 3 weeks later due to ¿high white blood cells count.¿ although several attempts were made to obtain further and clarifying information about this incident from family and caregivers, this was not possible.No information about the specific peristeen device, used by the patient at the time of the event, was available.However, it appears valid to accept that this case concerns a bowel perforation in relation peristeen irrigation, which is a well-known complication to anal irrigation and described in the instructions for use (ifu).
Additional Manufacturer Narrative
Medical assessment has been added to the "report incident description" field.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Common Device Name: PERISTEEN ANAL IRRIG SYSTEM
• 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: 13559156
• Report Number: 3006606901-2022-00004
• Device Sequence Number: 19780264
• Product Code: KNT
• UDI-Device Identifier: 05708932544528
• UDI-Public: 05708932544528
• 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: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2022

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?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 2912901400
• Device Catalogue Number: 29129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/18/2022
• Initial Report FDA Received Date: 02/18/2022
• Supplement Report FDA Received Date: 03/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• 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: 63 YR
• Patient Sex: Male