MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; TUBES, GASTROINTESTINAL (AND ACCESSORIES)

Model Number 2912101001

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

Patient Problems Abdominal Pain (1685); Peritonitis (2252); Bowel Perforation (2668)

Event Date 09/14/2020

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.(b)(4).

Event Description

This case concerns a patient using peristeen due to disabling fecal incontinence.On september 14th, at home, the patient had the first irrigation with peristeen under supervision of a stoma care nurse.The patient was sitting at the toilet inserting the catheter delicately and after 1,5 pumps, for inflation of the balloon, the patient immediately stopped due to a feeling of discomfort.He instilled 250 ml of water.The patient felt a sensation of blockage and stopped the irrigation on the advice from the stoma care nurse.There was no blood on the rectal catheter nor in the stool.In the afternoon, the patient experienced an intense abdominal pain followed by fever (38,5 degrees c) the next day and persistence of the abdominal pain.On september 15th, the patient consulted the gastroenterologist and was referred urgently to a colorectal surgeon who prescribed a ct-scan.The ct-scan confirmed a rectal perforation with the presence of air in the peritoneum and peritonitis.The patient was hospitalized for 10 days and treated with antibiotics.The patient was still being treated with antibiotics on october 8th with no complications.The patient will see his surgeon on 12 october regarding his persistent and very incapacitating colorectal disorder.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: TUBES, GASTROINTESTINAL (AND ACCESSORIES)
• 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: usllam linda linsday-ambroziak ; holtedam 1; humlebæk 3050 ; DA 3050
• MDR Report Key: 10718287
• MDR Text Key: 212729018
• Report Number: 3006606901-2020-00013
• 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
• Type of Report: Initial
• Report Date: 10/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 2912101001
• Device Lot Number: 7535296
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/01/2020
• 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
• Patient Age: 61 YR
• Patient Weight: 80