MAUDE MDR 7682779

MDR report key
7682779
Report number
1423395-2018-00038
Event key
0
Event type
3
Date of event
2018-06-19
Date received
2018-07-12
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
BERMON PUNZALAN
Address
THREE LAKES DRIVE NORTHFIELD IL 60093 US
Phone
224-224-2249
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1CATH N0 1 STRL MMC PACKMEDLINE INDUSTRIES INC.OESDYNJ46134CUNKR N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-07-1201. O

Event Narratives#

N

Patient 1

IT WAS REPORTED THAT DURING A LEFT HEART CATHETERIZATION WITH INTERVENTION, UPON REMOVAL OF THE CATHETER FROM THE PATIENT, A "THROMBUS" WAS NOTED ON THE CATHETER, REPORTEDLY FROM THE LINTING OF BLUE OR TOWEL. PER REPORT, THE BLUE OR TOWEL WAS INSPECTED BEFORE USE AND LINTING WAS NOT IDENTIFIED AT THAT TIME. IT WAS DENIED THAT THE TOWEL WAS USED TO WIPE THE CATHETER. PER REPORT, THE FACILITY WAS ABLE TO PULL OUT THE "THROMBUS"ON THE CATHETER; HOWEVER, WAS UNABLE TO DETERMINE IF ANY LINT REMAINED IN THE PATIENT. THE PATIENT DID NOT REQUIRE ADDITIONAL SEDATION AS A RESULT OF THIS INCIDENT. THE PATIENT WAS DISCHARGED TO HOME FOLLOWING THE PROCEDURE. THERE WAS NO SERIOUS INJURY REPORTED. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. THE SAMPLE WAS DISCARDED AND WAS NOT RETURNED FOR EVALUATION. A ROOT CAUSE COULD NOT BE DETERMINED AT THIS TIME. NO ADDITIONAL INFORMATION IS AVAILABLE. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

D

Patient 1

IT WAS REPORTED THAT DURING A LEFT HEART CATHETERIZATION WITH INTERVENTION, UPON REMOVAL OF THE CATHETER FROM THE PATIENT, A "THROMBUS" WAS NOTED ON THE CATHETER, REPORTEDLY FROM THE LINTING OF BLUE OR TOWEL.