DYNJ0378596F

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-18 for DYNJ0378596F manufactured by Medline Industries Inc..

Event Text Entries

[120693438] It was reported that during a right and left heart cath procedure the forceps punctured an unidentified femoral artery. Reportedly, this occurred as the cardiologist was using the forceps to spread the patient's skin after making an incision. Manual pressure was "held for hemostasis" over the puncture site. The patient was not under general anesthesia at the time of this incident. The procedure did not last longer than expected. There was no reported impact to the procedure, the patient, or the patient's stability. After an unidentified period of time a femoral ultrasound was performed with no adverse findings reported. No sample was returned to the manufacturer for evaluation. A root cause could not be determined. Due to the reported incident, and in an abundance of caution, this medwatch is being filed. If additional information becomes available a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[120693439] It was reported that during a right and left heart cath procedure the forceps punctured an unidentified femoral artery.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423395-2018-00044
MDR Report Key7887313
Date Received2018-09-18
Date of Report2018-09-18
Date of Event2018-08-24
Date Mfgr Received2018-08-24
Date Added to Maude2018-09-18
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactNIGEL VILCHES
Manufacturer StreetTHREE LAKES DRIVE
Manufacturer CityNORTHFIELD IL 600932753
Manufacturer CountryUS
Manufacturer Postal600932753
Manufacturer Phone2249311458
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Generic NameFORCEPS IN CATH LAB DRAPE PACK-LF
Product CodeOES
Date Received2018-09-18
Catalog NumberDYNJ0378596F
Lot Number18GBN757
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDLINE INDUSTRIES INC.
Manufacturer AddressTHREE LAKES DRIVE NORTHFIELD IL 600932753 US 600932753


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2018-09-18

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