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 2013-09-13 for PORT-A-CATH II INTRASPINAL IMPLANTABLE ACCESS SYSTEM 21-1500 manufactured by Smiths Medical.

Event Text Entries

[3864496] From clinical trial study organizer: it was reported that the device was implanted in patient for administration of clinical trial drug on (b)(6) 2011. According to report, it was difficult to deliver clinical trial drug on (b)(6) 2013 and x-ray identified possible fracture and displacement of device catheter from intrathecal space. The device was surgically explanted on (b)(6) 2013: the removed portion of used catheter was observed to have fractured into 2 pieces. A replacement device was implanted. Patient was released from hospital care on (b)(6) 2013. No permanent adverse effects reported.
Patient Sequence No: 1, Text Type: D, B5


[11197419] Customer has not yet returned the device to the manufacturer for device evaluation. When and if the device becomes available and is returned and evaluated, the manufacturer will file a follow-up report detailing the results of the evaluation.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2183502-2013-00520
MDR Report Key3351862
Report Source00,01,06
Date Received2013-09-13
Date of Report2013-09-13
Date of Event2013-08-09
Date Facility Aware2013-08-09
Report Date2013-09-13
Date Reported to FDA2013-09-13
Date Mfgr Received2013-08-15
Device Manufacturer Date2011-05-01
Date Added to Maude2013-09-18
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 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
Product CodeLNY
Date Received2013-09-13
Model Number21-1500
Catalog Number21-1500
Lot Number2006077
ID NumberNA
Device Expiration Date2016-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age2 YR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerSMITHS MEDICAL
Manufacturer AddressST. PAUL MN US


Patients

Patient NumberTreatmentOutcomeDate
101. Hospitalization; 2. Required No Informationntervention 2013-09-13

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