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

Model Number 2912901400

Device Problem Device Handling Problem (3265)

Patient Problem Internal Organ Perforation (1987)

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

According to the available information, this case concerns a (b)(6) female patient with sci at t2 and related neurogenic bowel dysfunction due to a motor vehicle accident in 2016.Due to symptoms related to neurogenic bowel dysfunction (incontinence, time consuming bowel management, incomplete evacuation), daily tai with 350ml water was initiated on (b)(6) 2021 using the small catheter with 2 pumps of the balloon.Training was a 2-hour training session at the physician¿s office with a 1-hour demonstration followed by the mother of the patient performing the irrigation.On (b)(6) 2021 at the second attempt at home after the initial training (first irrigation was successful) the mother accidently inserted the catheter into the vagina instead of her rectum while the patient was seated on a shower chair and then inflated the balloon with 2 pumps.The patient had instant discomfort/pain and immediate vaginal bleeding.The patient was admitted to emergency 1 hour after the incident where a ct scan of the abdomen and pelvis confirmed a vaginal traumatic laceration.The cervix and cervical os were intact but lateral to the cervix at the level of the right vaginal well "externing" ¾ of the way down the vaginal canal, there was a full thickness laceration of the vaginal wall.The laceration was repaired using a chromic suture 4.0.The patient was discharged the next day.

Manufacturer Narrative

Annexes c and d have been changed and annex g has been added to include code g04023 - catheter.

• Brand Name: PERISTEEN TRANSANAL IRRIGATION SYSTEM WITH CATHETER
• Type of Device: 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: 12820318
• MDR Text Key: 282000684
• Report Number: 3006606901-2021-00031
• Device Sequence Number: 1
• Product Code: KNT
• UDI-Device Identifier: 05708932544528
• UDI-Public: 05708932544528
• 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,Followup
• Report Date: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Model Number: 2912901400
• Device Catalogue Number: 29129
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/11/2022
• 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): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 12 YR
• Patient Sex: Female