FDA.reportPublic FDA data

MAUDE MDR 6490060

MDR report key
6490060
Report number
3009211636-2017-05077
Event key
0
Event type
3
Date of event
2017-03-30
Date received
2017-04-13
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
EDWARD ALMEIDA
Address
15 HAMPSHIRE ST MANSFIELD MA 02048 US
Phone
508-508-5084
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1PALINDROMECATHETER, HEMODIALYSIS, IMPLANTED, COATEDCOVIDIEN MANUF. SOLUTIONS SANYU8888145043P8888145043P1615300164* N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-04-130

Event Narratives#

N

Patient 1

AN INVESTIGATION IS CURRENTLY UNDERWAY; UPON COMPLETION THE RESULTS WILL BE FORWARDED.

D

Patient 1

IT WAS REPORTED TO COVIDIEN ON (B)(6) 2017 THAT A CUSTOMER HAD AN ISSUE WITH A DIALYSIS CATHETER.THE CUSTOMER STATES ONCE THE CATHETER WAS IMPLANTED AND AFTER HAVING REMOVED THE METAL GUIDE, THE VENA TRAC WAS WITHDRAWN; THE FIRST WITHOUT A PROBLEM. THE SECOND, WHEN REMOVED, BROKE AT THE BEGINNING OF THE EXTENSIONS OF THE CATHETER LEAVING THE REST OF THE VENATRACK IN THE INTERIOR, SO IT WAS NECESSARY TO REPLACE THE CATHETER.

N

Patient 1

A DEVICE HISTORY RECORD (DHR) REVIEW REVEALED NO DISCREPANCIES THAT MAY HAVE CONTRIBUTED TO A COMPLAINT OF THIS FAILURE MODE. ALL QUALITY ASSURANCE TESTING PERFORMED DURING MANUFACTURING WAS ACCEPTABLE. THE QUALITY ASSURANCE REVIEW OF THE VISUAL, PHYSICAL AND DIMENSIONAL EVALUATION RESULTS INDICATED THAT THE PRODUCT MET SPECIFICATION REQUIREMENTS. IN ADDITION, ALL DHRS ARE REVIEWED FOR ACCURACY PRIOR TO PRODUCT RELEASE. THE PHYSICAL SAMPLE INVOLVED IN THE REPORTED INCIDENT WAS NOT RETURNED FOR EVALUATION. ONE PHOTO WAS PROVIDED BY THE CUSTOMER. VISUAL EVALUATION OF THIS PHOTO WAS PERFORMED AND IT WAS OBSERVED THAT THE CATHETER WAS INSIDE THE PATIENT. ALSO, IN THIS PICTURE, IT WAS OBSERVED ONE STYLET WAS BROKEN AND SHOWED SIGNS OF MANIPULATION. AS PART OF THE TESTING, THE COMPLAINTS TECHNICIAN TRIED TO REPLICATE THE ISSUE BY TRYING TO REMOVE THE STYLET WHEN IT WAS STILL ATTACHED TO THE GUIDE WIRE. THIS CAUSED A FORCE ON THE ARTERIAL LUMEN STYLET THAT CAUSES IT TO BREAK SIMILAR IN APPEARANCE TO THE REPORTED ISSUE. AN ISHIKAWA DIAGRAM WAS USED TO DETERMINE THE POTENTIAL CAUSES FOR THIS EVENT. ACCORDING TO THE PHOTO EVALUATION, THE REPORTED CONDITION WAS IDENTIFIED AND CON FIRMED. A MANUFACTURING ISSUE COULD NOT BE RELATED TO THE REPORTED CONDITION PER THE AVAILABLE INFORMATION. THE MOST PROBABLE CAUSE WAS IDENTIFIED AS CUSTOMER MISUSE, INADEQUATE MANIPULATION OF THE COMPONENTS. NO TRIGGERS OR TRENDS WERE IDENTIFIED AND NO HARM WAS REPORTED IN THIS COMPLAINT THEREFORE FURTHER CORRECTIVE AND PREVENTIVE ACTIONS (CAPA) ARE NOT REQUIRED AT THIS MOMENT. IT MUST BE NOTED THAT IN-PROCESS CONTROLS, SUCH AS PERSONNEL TRAINING, INCOMING QUALITY ACCEPTANCE TESTING FOR RAW MATERIAL, 100% VISUAL INSPECTION, AND VISUAL ACCEPTANCE SAMPLING, ARE IN PLACE TO PREVENT NONCONFORMING PRODUCT FROM LEAVING THE MANUFACTURING OPERATIONS. NO ADDITIONAL ACTIONS ARE REQUIRED. THIS COMPLAINT WILL BE USED FOR TRACKING AND TRENDING PURPOSES. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

D

Patient 1

THE CUSTOMER STATES ONCE THE CATHETER WAS IMPLANTED AND AFTER HAVING REMOVED THE METAL GUIDE, THE VENA TRAC WAS WITHDRAWN; THE FIRST WITHOUT A PROBLEM. THE SECOND, WHEN REMOVED, BROKE AT THE BEGINNING OF THE EXTENSIONS OF THE CATHETER LEAVING THE REST OF THE VENATRACK IN THE INTERIOR, SO IT WAS NECESSARY TO DO THE PROCEDURE AGAIN AND TO DO THE REPLACEMENT OF THE CATHETER.