MAUDE Adverse Event Report: COLOPLAST A/S PED FOLYSIL CATH 1.5ML CH06/5; SILICONE FOLEY CATHETER

Model Number AA61061002

Device Problems Deflation Problem (1149); Malposition of Device (2616)

Patient Problem Abdominal Pain (1685)

Event Date 10/13/2017

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 of 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, a (b)(6) years old boy underwent a reconstructive long hypospadias-correction surgery.Next day an aa6106 catheter was placed; 5 hours after the catheter was placed, a nurse has determined, the balloon was deflated and the urethra again contracted.A further, several hours lasting surgery has been implemented on the same day and a new aa6106 was placed, the balloon was tested and considered to be good.Because on (b)(6) 2017 the patient has suffered from abdominal pain, an examination was done by a physician.A kidney congestion was determined and the catheter was found slip out from its formerly placed position (the balloon was deflated), which caused the urethra became contracted again.The nurse considers, the catheter could not be pulled out by the patient or other person, due to the presence of the tamponade.The surgeon expects potentially lifelong consequences and procedures e.G.Urethrotomian slit for the patient.It is probable the parents will claim for recourse/redress.

Manufacturer Narrative

This follow-up mdr is created to document the evaluation of the returned sample: after receiving this complaint, we searched and found no other complaints for lot n° 5389479.Checking the quality databases revealed no anomaly in connection with the described defect.On the 6 november we received one used contaminate sample, we decontaminated it and tested the balloon with inflating 1ml of air with a syringue then the balloon bursts.We tested the funnel and the valve with clamps we haven't seen any leakage ,no problem detected after we tested the sample with a technician of our depart.R&d and we have realized : test 1 : cutting the balloon to see the inflation channel : result correct.Test 2 : checking the thickness around the inflation channel : result correct.Test 3 : checking the anti-reflux valve by inserting a needle into the inflation canal and sending air through the valve and putting the sample into the water: result correct no leakage from it.From experience, silicone balloon deflation could come from various causes.In this cases we can not identify any specific root cause as unsufficient information has been provided to do so.Our rmf criq216 (risks n° from21601 to 21604 and 21610) identifie risks which are in the green area and considered acceptable no other corrective action will be implemented as the specific trend for balloon issue and this product family has an average during the last 12 month of 20 ppm which is considered acceptable as per the threshold of 25ppm.Based on the above, this complaint is confirmed as a product defect.

• Brand Name: PED FOLYSIL CATH 1.5ML CH06/5
• Type of Device: SILICONE FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 7010315
• MDR Text Key: 91361859
• Report Number: 9610711-2017-00025
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 03600040126844
• UDI-Public: 03600040126844
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 11/28/2017

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: Health Professional
• Device Model Number: AA61061002
• Device Catalogue Number: AA61061002
• Device Lot Number: 5389479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2017
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/19/2017
• Initial Date FDA Received: 11/08/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 5 YR