BAXTER 9 FRENCH MULTILUMEN CATHETER M3L 9FHK1 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-09-30 for BAXTER 9 FRENCH MULTILUMEN CATHETER M3L 9FHK1 * manufactured by Baxter Healthcare Corp..

Event Text Entries

[158561] Pt with 9 french multilumen catheter placed during heart surgery experienced a neurological event during rewiring of the catheter postoperatively. Ct scan showed a thrombus in the right internal carotid artery which was treated with intra-arterial t-pa. Despite aggressive therapy, the pt experienced progressive left brain swelling and eventually slipped into a coma and died. The family refused autopsy. The co was notified immediately.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number242803
MDR Report Key242803
Date Received1999-09-30
Date of Report1999-09-27
Date of Event1999-08-24
Date Facility Aware1999-08-24
Report Date1999-09-27
Date Reported to FDA1999-09-27
Date Reported to Mfgr1999-09-27
Date Added to Maude1999-10-05
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag0
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use0
Previous Use Code0
Event Type3
Type of Report3

Device Details

Brand NameBAXTER 9 FRENCH MULTILUMEN CATHETER
Generic NameCATHETER
Product CodeJCY
Date Received1999-09-30
Model NumberM3L 9FHK1
Catalog Number*
Lot Number*
ID Number*
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age*
Implant FlagN
Date Removed*
Device Sequence No1
Device Event Key235232
ManufacturerBAXTER HEALTHCARE CORP.
Manufacturer AddressONE BAXTER PKWY DEERFIELD IL 600154633 US
Baseline Brand NameADVANCED VENOUS ACCESS (AVA) CATHETER
Baseline Generic NameCENTRAL VENOUS ACCESS CATHETER
Baseline Model NoM3L9FHKI
Baseline Catalog NoNA
Baseline IDNA
Baseline Shelf Life ContainedY
Baseline Shelf Life [Months]18
Baseline PMA FlagN
Baseline 510K PMNY
Premarket NotificationK981909
Baseline PreamendmentN
Baseline TransitionalN
510k ExemptN


Patients

Patient NumberTreatmentOutcomeDate
101. Death 1999-09-30

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