CODMAN NEURO UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-09-19 for CODMAN NEURO UNK manufactured by Codman Neuro.

Event Text Entries

[55750140] An (b)(6) male admitted with leg weakness and fall, no loss of consciousness or head trauma on (b)(6) 2016. Pt had a recent history of tachy-brady syndrome and was being followed by cardiology with plan for a permanent pacemaker placement. Pt had a ct of his chest/abdomen and pelvis showing widespread metastatic disease. Mri of the thoracic spine was ordered to rule out spine metastasis in the setting of leg weakness. Pt did have a significant past history of peripheral vascular disease with history of abdominal aortic aneurysm repair, with left leg bypass graft in addition to aneurysm surgery in 1982 or 1983 at (b)(6) hospital. However, there was no readily available info regarding clipping of aneurysm. Pt was alert and oriented and had the mri check list presented to him twice, once on the nursing unit and then in the mri suite and pt denied having any metal in his body. During the mri, pt became unresponsive and had a code stroke called, repeat ct head scan showed a large intracranial bleed. Findings discussed with family and decision was made for comfort care and pt expired on (b)(6) 2016. Final autopsy results received on (b)(6) 2016 with cause of death attributed to the rupture of the aneurysm of the right posterior communicating artery. The previously placed aneurysm clips were present: one sundt-kees clip at the point to tri-furcation of the right mca and one mcfadden clip at the a1 segment of the left aca. There was no evidence of vascular tear or damage at or adjacent to the clips, or evidence of displacement of the clips as both clips were present at their original location as referenced on the cranial ct's.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number5980606
MDR Report Key5980606
Date Received2016-09-19
Date of Report2016-09-19
Date of Event2016-08-12
Date Facility Aware2016-08-12
Report Date2016-09-19
Date Reported to FDA2016-09-19
Date Reported to Mfgr2016-09-19
Date Added to Maude2016-09-27
Event Key0
Report Source CodeUser Facility report
Manufacturer LinkN
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag0
Reprocessed and Reused Flag3
Reporter OccupationRISK MANAGER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCODMAN NEURO
Generic NameSUNDT-KEES AND MCFADDEN ANEURYSM CLIPS
Product CodeHCH
Date Received2016-09-19
Model NumberUNK
Catalog NumberUNK
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Age18 YR
Device Eval'ed by MfgrI
Device Sequence No1
Device Event Key0
ManufacturerCODMAN NEURO
Manufacturer AddressRAYNHAMN MA 02767 US 02767


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2016-09-19

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