FDA.reportPublic FDA data

MAUDE MDR 8139579

MDR report key
8139579
Report number
3007795799-2018-00005
Event key
0
Event type
3
Date of event
2018-11-06
Date received
2018-12-06
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
BRIAN BOSCH
Address
181 CHESHIRE LANE SUITE 100 PLYMOUTH MN 55441 US
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1SECURACATHSUBCUTANEOUS ENGINEERED STABILIZATION DEVICEINTERRAD MEDICALOKCSCR-01400110R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-12-060

Event Narratives#

N

Patient 1

A 5F TRIPLE LUMEN BARD POWERPICC HF WAS SENT TO INTERRAD MEDICAL FOR EVALUATION. THE CATHETER WAS FOUND TO HAVE TWO SPLITS, ONE IN THE GRAY LUMEN BETWEEN THE HUB AND 0 CM MARK, AND ONE ON THE RED LUMEN CENTERED ON THE 0 CM MARK APPROXIMATELY 1 CM IN TOTAL LENGTH. THE REPORTING ACCOUNT DID NOT PROVIDE THE SECURACATH DEVICE OR LOT NUMBER FOR EVALUATION. WITHOUT THOSE THINGS, AN INVESTIGATION OF COMPONENT AND PROCESS HISTORY OR PERFORMANCE OF THE SECURACATH DEVICE COULD NOT BE CONDUCTED. THIS IS 1 OF 2 CATHETERS THAT LEAKED WHILE BEING SECURED WITH A SECURACATH THAT WERE BOTH FROM THE SAME BARD MANUFACTURING LOT# RECV2555. AT THIS TIME THERE IS NO INFORMATION TO INDICATE THAT SECURACATH DEVICE FAILED TO MEET ITS PRODUCT SPECIFICATIONS. EXTENSIVE ENGINEERING EVALUATIONS HAVE SHOWN THAT THE SECURACATH DEVICE IS EFFECTIVE AT HOLDING A BARD POWER PICC CATHETER IN PLACE WHILE NOT NEGATIVELY IMPACTING CATHETER PERFORMANCE. TESTING ON THIS SPECIFIC TYPE CATHETER HAS BEEN DONE AND NO CONCERNS HAVE BEEN IDENTIFIED. TESTING IS DONE WITH THE SECURACATH POSITIONED AT THE "0" MARK ON REVERSE TAPERED CATHETERS TO REFLECT THE MOST CHALLENGING FOR FLOW RESTRICTION/CATHETER COMPRESSION. SPECIFIC TESTING ON BARD POWERPICC CATHETERS ATTEMPTED TO FORCE A CATHETER BREAK BY PURPOSEFULLY PINCHING THE CATHETER WITH THE BODY OF THE SECURACATH DEVICE REPEATEDLY, WHICH WOULD BE A WORST CASE SCENARIO OF INCORRECT USE OF A SECURACATH DEVICE, WITH NO CATHETER FAILURES CREATED. BASED ON PREVIOUS TESTING AND THE TYPE OF SPLITS FOUND IN THE CATHETER, THIS WAS MOST LIKELY AN EXTRUSION/MATERIAL ISSUE WITH THE CATHETER AND THE CATHETER COULD HAVE FAILED WITHOUT THE USE OF SECURACATH. A SEARCH OF THE MAUDE DATABASE SHOWS 11 BARD POWERPICCS OF DIFFERENT SIZES AND TYPES HAVING REPORTED LEAKS FROM (B)(6) 2018 TO (B)(6) 2018 WITHOUT THE USE OF SECURACATH. THIS DEMONSTRATES THAT DAMAGE IS SEEN ON BARD POWERPICCS ON THE REVERSE TAPERED PORTION FROM THE HUB TO THE 7 CM WITHOUT THE USE OF A SECURACATH DEVICE. IF THE SECURACATH IS PLACED PER THE IFU AND DRESSED PROPERLY AFTERWARDS, A CATHETER LEAK DURING USE IS RELATED TO CATHETER CONSTRUCTION AND NOT CAUSED BY THE SECURACATH DEVICE. THIS REPRESENTS ALL OF THE INFORMATION THAT INTERRAD MEDICAL WAS ABLE TO OBTAIN AT THIS TIME. IF ANY NEW INFORMATION COMES TO LIGHT IN THE FUTURE A FOLLOW UP REPORT WILL BE SUBMITTED TO UPDATE THIS REPORT.

D

Patient 1

A 5F TRIPLE LUMEN BARD POWERPICC HF WAS PLACED AND SECURED WITH A 5F SECURACATH ON (B)(6) 2018. CATHETER BEGAN LEAKING AND WAS NOTIFIED BY BEDSIDE NURSE ON (B)(6) 2018. CATHETER WAS REPLACED BY REWIRING. THERE WERE TWO SPLITS IN THE CATHETER, ONE IN THE GRAY LUMEN BETWEEN THE HUB AND 0 CM MARK, AND ONE ON THE RED LUMEN CENTERED ON 0 CM MARK APPROXIMATELY 1 CM IN TOTAL LENGTH. CATHETER WAS REPORTED TO HAVE 3 CM EXTERNAL LENGTH.