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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MARVAO MEDICAL NEXSITE HD STEPPED TIP; HEMODIALYSIS CATHETER

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MARVAO MEDICAL NEXSITE HD STEPPED TIP; HEMODIALYSIS CATHETER Back to Search Results
Catalog Number NEXHD1552801
Device Problems Hole In Material (1293); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Code Available (3191)
Event Date 02/01/2017
Event Type  Injury  
Manufacturer Narrative
A review of the manufacturing documentation confirmed that the lot met the specification requirements.The review found no deviations or non-conformances that would have contributed to the reported complaint.Taking into consideration the evaluation conducted and the details of the complaint, this investigation was assigned the most probable root cause of an anticipated procedural complication.A complaint with a most probable root cause classification of an anticipated procedural complication indicates that a device related root cause does not apply and the complaint is due to a known effect of the procedure.A secondary root cause of not confirmed is assigned as the most probable root cause classification with regards to the reported hole in the catheter.The complaint included a device review (visual, physical and/or performance testing) which showed no evidence of the alleged issue or any defect which could have contributed to the event.Product analysis did not confirm any leaks along the length of the catheter.
 
Event Description
(b)(4): the nexsite device was successfully placed on (b)(6) 2016.On (b)(6) 2017, a catheter malfunction presented as having poor blood flows during the dialysis session.The catheter was replaced with another one (not a nexsite hd catheter) and the event resolved on the same date.Subject is now dialysing well with no complications.The procedure note states that there was a fibrin sheath in the brachiocephalic vein in addition to there being a "hole" in the catheter.
 
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Brand Name
NEXSITE HD STEPPED TIP
Type of Device
HEMODIALYSIS CATHETER
Manufacturer (Section D)
MARVAO MEDICAL
innovation in business centre
gmit, dublin road
galway, H91 D CH9
EI  H91 DCH9
Manufacturer Contact
fiona geraghty
innovation in business centre,
gmit, dublin road
galway, galway H91 D-CH 9
EI   H91 DCH 9
91759301
MDR Report Key6383312
MDR Text Key69209547
Report Number3008110587-2017-00002
Device Sequence Number1
Product Code MSD
UDI-Device Identifier05391525640020
UDI-Public(01)05391525640020(17)161101(10)42550
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121933
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation Other
Type of Report Initial
Report Date 02/09/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Physician
Device Expiration Date11/01/2016
Device Catalogue NumberNEXHD1552801
Device Lot Number42550
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2017
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 02/09/2017
Initial Date FDA Received03/07/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/07/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Treatment
ALLOPURINOL; CARVEDILOL; FUROSEMIDE; GLYBURIDE; LISINOPRIL; NIFEDIPINE; TIROSINT
Patient Outcome(s) Required Intervention;
Patient Age67 YR
Patient Weight68
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