PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06 report with the FDA on 2013-07-01 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical.

Event Text Entries

[3653986] From clinical trial study organizer: it was reported that the device was implanted in pt for administration of clinical trial drug on (b)(6) 2012. According to reporter, the device catheter migrated out of the subarachnoid space, so the clinical trial drug was administered via lumbar puncture. The pt was admitted to hospital care on (b)(6) 2013 and the system was removed and replaced on (b)(6) 2013. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[11028504] The device is currently being evaluated; the mfr will file a follow-up report detailing the results of the eval once it is completed.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2013-00362
MDR Report Key3212768
Report Source00,01,06
Date Received2013-07-01
Date of Report2013-06-28
Date of Event2013-01-02
Date Facility Aware2013-01-02
Report Date2013-06-28
Date Reported to FDA2013-06-28
Date Mfgr Received2013-01-10
Device Manufacturer Date2011-06-01
Date Added to Maude2013-07-10
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 ContactPETE HIRTE
Manufacturer Street1265 GREY FOX RD.
Manufacturer CityST. PAUL MN 55112
Manufacturer CountryUS
Manufacturer Postal55112
Manufacturer Phone6516287384
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NamePORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM
Generic NameLNY - CATHETER, PERCUTANEOUS, LONG TERM, INTRASPINAL
Product CodeLNY
Date Received2013-07-01
Model Number21-1500
Catalog Number21-1500
Lot Number2012443
ID NumberNA
Device Expiration Date2016-05-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age18 MO
Device Eval'ed by MfgrN
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL
Manufacturer AddressST. PAUL MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Required No Informationntervention 2013-07-01

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