FDA.reportPublic FDA data

MAUDE MDR 3693330

MDR report key
3693330
Report number
3007795799-2014-00012
Event key
0
Event type
3
Date of event
2013-11-15
Date received
2014-03-11
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
500
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Address
181 CHESHIRE LN N SUITE 100 PLYMOUTH MN 55441 US
Phone
763-763-7632
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SECURACATHSECUREMENT FOR INTRAVASCULAR DEVICESINTERRAD MEDICAL INCOKCSCR-1400100UNKN N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12014-03-110

Event Narratives#

D

Patient 1

THE RISK MANAGER AT (B)(6) REPORTED THAT THERE WERE REPORTS OF DIFFICULTY IN REMOVING THE ANCHOR FROM PATIENT'S WITH TISSUE SCAR ADHESION AROUND THE DEVICE. THE NURSE(S) WERE TRYING TO REMOVE THE ANCHOR GENTLY TO AVOID HURTING THE PATIENT RESULTING IN DIFFICULTY REMOVING THE ANCHOR AND DISCOMFORT FOR THE PATIENT. THERE WERE NO DEVICE MALFUNCTION AN NO ADVERSE EVENT. THIS INCIDENT OCCURRED DURING THE EARLY IMPLEMENTATION PHASE OF THE DEVICE, WHEN MANY CLINICIANS WERE JUST BEGINNING TO USE THE DEVICE. THE COMPANY HAS FOUND THE REMOVAL PROCESS BECOMES EASIER ONCE EXPERIENCE HAS BEEN OBTAINED. ON SOME PATIENTS, ESPECIALLY WITH LONGER DWELL TIMES, THE ANCHORS BECOME MORE EMBEDDED IN THE TISSUE. FOR THESE CASES, THE ANCHOR NEEDS TO BE PULLED OUT USING A SWIFT, DELIBERATE TUG. THE SMALL, BLUNT ANCHORS STRAIGHTEN WHEN PULLED OUT WITHOUT DAMAGING THE SKIN. THE REMOVAL OF SECURACATH, WHEN DONE CORRECTLY, CAN BE EQUATED TO THE REMOVAL OF A HUBER NEEDLE FROM AN IMPLANTED PORT IN THAT SOME PATIENTS MAY EXPERIENCE MOMENTARY PAIN IF ANY UPON REMOVAL WHICH QUICKLY SUBSIDES UPON COMPLETION OF THE REMOVAL PROCEDURE.

N

Patient 1

THERE WERE NO DEVICE MALFUNCTION NOR HARM TO THE PATIENT. TISSUE GROWTH AROUND THE ANCHOR IS NORMAL AND REMOVAL OF THE ANCHOR UNDER THESE CONDITION IS DESCRIBED IN THE IFU. A RAPID DELIBERATE TUG OF THE ANCHOR IS REQUIRED TO REMOVE THE ANCHOR FROM THE SUBCUTANEOUS SPACE IF TISSUE GROWTH IS PRESENT. THIS GENERALLY RESULTS IN LITTLE OR NO DISCOMFORT FROM THE PATIENT AND IS PREFERRED TO THE GENTLE TENTATIVE ANCHOR REMOVAL.