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Adverse Event Report

DELTEC, INC. PORT-A-CATH PERITONEAL IMPLANTABLE ACCESS SYSTEM   back to search results
Model Number 21-2000
Device Problems Explanted; Fragmentation
Event Date 01/29/2003
Event Type  Injury  
Manufacturer Narrative

The device was returned and evaluated. A portal with an attached 1/2-inch section of catheter that had been purposely cut during the explant procedure and a second section of unattached cuffed catheter 3/4-inch in length were returned for evaluation. One end of the unattached length of catheter was jagged and rough in appearance just distal to the polyester cuff. This damage is visually consistent with catheter fracture, unable to determine exactly how the fracture came to be.

 
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Brand NamePORT-A-CATH PERITONEAL IMPLANTABLE ACCESS SYSTEM
Type of DeviceIMPLANTABLE ACCESS SYSTEM
Baseline Brand NamePORT-A-CATH PERITONEAL IMPLANTABLE ACCESS SYSTEM
Baseline Generic NameIMPLANTABLE ACCESS SYSTEM
Baseline Catalogue Number21-2000
Baseline Model Number21-2000
Other Baseline ID NumberNONE
Baseline Device FamilyPORT-A-CATH PERITONEAL IMPLANTABLE ACCESS SYSTEM
Baseline Device 510(K) NumberK864552
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed03/31/1987
Manufacturer (Section F)
DELTEC, INC.
1265 grey fox rd.
st. paul MN 55112
Manufacturer (Section D)
DELTEC, INC.
1265 grey fox rd.
st. paul MN 55112
Manufacturer Contact
pete hirte
1265 grey fox rd
st paul , MN 55112
(651) 628 -7384
Device Event Key439503
MDR Report Key450510
Event Key426626
Report Number2183502-2003-00004
Device Sequence Number1
Product CodeLJT
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Invalid Data
Type of Report Initial
Report Date 03/03/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/10/2003
Is This An Adverse Event Report? No
Device Operator Health Professional
Device MODEL Number21-2000
Device Catalogue Number21-2000
Device LOT Number26781
Was Device Available For Evaluation? No
Date Returned to Manufacturer02/19/2003
Is The Reporter A Health Professional? No Answer Provided
Was the Report Sent to FDA? No
Distributor Facility Aware Date01/29/2003
Device Age5 yr
Event Location AMBULATORY SURGICAL Facility
Date Manufacturer Received02/06/2003
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1997
Is The Device Single Use? Yes
Is the Device an Implant? Yes
Is this an Explanted Device?
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 03/10/2003 Patient Sequence Number: 1
#TreatmentTreatment Date
1,NONE,

Database last updated on January 30, 2009

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