CDS983965D

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-05-03 for CDS983965D manufactured by Medtronic.

Event Text Entries

[145771962] It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient. Reportedly, the break occurred while peeling back the line's securement tape. When the break was identified, the remaining part of the line was clamped and the exposed end was covered. The medtronic set cath placement pressure line was required to be removed via an unidentified surgical procedure. No impact or adverse effect to the patient or the patient's stability was reported to the pack manufacturer. No sample for evaluation was returned to the pack manufacturer. Due to the need for medical intervention to remove the medtronic set cath placement pressure line, this medwatch is being filed. If additional relevant information becomes available, a supplemental medwatch will be filed.
Patient Sequence No: 1, Text Type: N, H10


[145771963] It was reported that the tip of the medtronic set cath placement pressure line broke off into the patient.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1423395-2019-00017
MDR Report Key8579703
Date Received2019-05-03
Date of Report2019-05-03
Date of Event2019-04-09
Date Mfgr Received2019-04-15
Date Added to Maude2019-05-03
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 NameMEDTRONIC LINE IN DBD-OPEN HEART CDS
Product CodeOEZ
Date Received2019-05-03
Catalog NumberCDS983965D
Lot Number18GBQ946
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerMEDTRONIC
Manufacturer Address710 MEDTRONIC PARKWAY MINNEAPOLIS MN 554325604 US 554325604


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2019-05-03

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