MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; PERISTEEN PLUS ACC. UNIT REG.

Model Number 2914201006

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

Patient Problem Bowel Perforation (2668)

Event Date 01/09/2022

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

Coloplast was notified about an incident involving peristeen transanal irrigation system, resulting in bowel perforation.According to the available information, this case concerns a (b)(6) male with spina bifida, making naturally bowel opening impossible.For the last 27 years, he used laxatives and the irrigation system cardiomed, which no longer is commercially available.Digital rectal examination and coloscopy was performed prior to initiation of peristeen irrigation.During the first insertion ((b)(6) 2022) after training ((b)(6) 2022) the patient inserted the rectal catheter eventless and inflated the balloon with 4 pumps.However, after instillation of 100 ml water the patient experienced immediate pain, deflated the balloon, and removed the catheter and inspected blood in the toilet.Immediately after the episode, he contacted the training nurse, who advised immediate hospitalization.A ct-scan revealed a 45 mm defect in the distal sigmoideum with free air, intra and extraperitoneal.A hartmans procedure with end-colostomy was performed ((b)(6) 2022).It has been advised by the consultant surgeon that the patient is doing well post surgery and is in a good frame of mind.No further information is available at this time.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: PERISTEEN PLUS ACC. UNIT REG.
• 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: 13392945
• MDR Text Key: 288277667
• Report Number: 3006606901-2022-00003
• 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: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Model Number: 2914201006
• Device Lot Number: 8339186
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/09/2022
• Date Device Manufactured: 12/04/2021
• 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): Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male