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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SEQUENT MEDICAL INC., ALISO VIEJO, CA VIA 27 MICROCATHETER; CONTINUOUS FLUSH CATHETER

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SEQUENT MEDICAL INC., ALISO VIEJO, CA VIA 27 MICROCATHETER; CONTINUOUS FLUSH CATHETER Back to Search Results
Model Number VIA 27-154-01
Device Problem Positioning Problem (3009)
Patient Problems Death (1802); Intracranial Hemorrhage (1891)
Event Date 09/20/2017
Event Type  Death  
Event Description
The microcatheter via 27 was delivered into the aneurysm sack at the acom.As the web-device was advanced through the microcatheter, suddenly the distal tip of the microcatheter moved forward and perforated the aneurysm dome.The constrained web device within the microcatheter at this time has been around the a1 segment.The microcatheter and the whole tri-axial catheter system has been brought back in right position.Delivery of the web device has been continued.After unsheathing the web and having it properly opened in right position control angiogram has been performed, showing bleeding out of the aneurysm sack.Decision to detach the web has been made and detachment has been performed properly without any problems.At this stage of the procedure numerous attempts to stop the bleeding has been performed: using 2 scepter occlusion balloons, filling spaces around the implant with onyx, coiling at the residual neck proximal of the web 2 evd as emergency rescue activity has been performed in angio suite by neurosurgery team.Sequent personnel spoke with physicians after the case and discussed the difficult guidewire/catheter access of the aneurysm and subsequent build-up of tension in the micro-catheter system (neuronmax, cat 6f, via27) during web delivery (friction/resistance at the m1/a1 junction) that led to catheter movement and perforation.
 
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Brand Name
VIA 27 MICROCATHETER
Type of Device
CONTINUOUS FLUSH CATHETER
Manufacturer (Section D)
SEQUENT MEDICAL INC., ALISO VIEJO, CA
11 columbia
aliso viejo CA 92656
Manufacturer (Section G)
SEQUENT MEDICAL
11 columbia
aliso viejo CA 92656
Manufacturer Contact
curtis hanson
11 columbia
aliso viejo, CA 92656
9498309600
MDR Report Key6954846
MDR Text Key89497010
Report Number3008423090-2017-00002
Device Sequence Number1
Product Code KRA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K132652
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Other
Type of Report Initial
Report Date 10/16/2017
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? No
Device Operator Health Professional
Device Expiration Date05/31/2020
Device Model NumberVIA 27-154-01
Device Catalogue NumberFG27154-01
Device Lot Number17050502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 09/26/2017
Initial Date FDA Received10/17/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age68 YR
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