MAUDE Adverse Event Report: COLOPLAST A/S PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER; PERISTEEN BAG/RECTAL CATHETERS

Model Number 2912201006

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

Patient Problems Abdominal Pain (1685); Nausea (1970); Bowel Perforation (2668); Syncope/Fainting (4411); Gastrointestinal Hemorrhage (4476); Hematemesis (4478); Melena (4480)

Event Date 02/15/2021

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

This case involved a (b)(6) year-old patient who has been performing transanal irrigation 2-3 timers per week for many years.Due to the end users reduced dexterity the procedure is performed with the end-user inserting the catheter, and hereafter the partner inflates the balloon and instils water.On (b)(6) 2021 after the rectal catheter had been inserted without any difficulty, and her partner attempted to inflate the balloon with 1 pump severe pain was experienced.The procedure was stopped immediately.After an hour of rest the patient experienced severe pain and 2 episodes of rectal bleeding, fecal incontinence and vomiting.The patient was admitted to the hospital where further melena stools and hematemesis was experienced.She was diagnosed with a localized left iliac fossa perforation secondary to transanal irrigation.The patient was hospitalized for 5 days and treated with bowel rest and iv-antibiotics after which the symptoms resolved.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: PERISTEEN BAG/RECTAL CATHETERS
• 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 ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 11529388
• MDR Text Key: 241082180
• Report Number: 3006606901-2021-00005
• 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

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: 2912201006
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/23/2021
• Initial Date FDA Received: 03/19/2021
• 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
• Patient Age: 78 YR
• Patient Weight: 91