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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER CATHETER, PERCUTANEOUS

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MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER CATHETER, PERCUTANEOUS Back to Search Results
Model Number RFX058-130-08
Device Problem Material Perforation (2205)
Patient Problem Hemorrhage, Cerebral (1889)
Event Date 10/15/2019
Event Type  Injury  
Manufacturer Narrative

The device involved in the reported event will not be returned for evaluation as it was discarded; therefore, the event cause could not be determined. Correspondence has been sent out to the customer for images and additional information. Once correspondence has been received and the investigation has been completed, a supplemental report will be submitted. If information is provided in the future, a supplemental report will be issued.

 
Event Description

Medtronic received report that the medtronic guide catheter jumped up during embolization procedure causing the aneurysm to rupture. The physician was planning to use two medtronic flow divertor devices to treat two aneurysms. Prior to the event, the first medtronic flow divertor device was implanted in severely tortuous anatomy. Upon delivering the second flow divertor, the medtronic guide catheter was reported to ride up (due to the severely tortuous anatomy) and the proximal aneurysm ruptured. The flow divertor was placed. Bleeding was noted and an additional medtronic flow divertor was placed. The vessel was ballooned and inflated. An additional medtronic flow diverter was placed. The patient was sent to computed tomography (ct). Coils were placed the next day. The patient was reported to be alive and will possibly need to sacrifice the internal carotid artery (ica). The patient was undergoing embolization treatment of two aneurysms in the internal carotid artery (ica). The patient¿s vasculature was severe in tortuosity. Ancillary devices: synchro 2 guidewire, phenom 27 (ja19-086) microcatheter, navien. 058 (a88691) guide catheter, shuffle 6f 90cm sheath.

 
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Brand NameSUPPORT GUIDECATHETER
Type of DeviceCATHETER, PERCUTANEOUS
Manufacturer (Section D)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer (Section G)
MICRO THERAPEUTICS, INC. DBA EV3
9775 toledo way
irvine CA 92618
Manufacturer Contact
katcha taylor
9775 toledo way
irvine, CA 92618
9496801345
MDR Report Key9222611
MDR Text Key164115915
Report Number2029214-2019-01061
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK110055
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial
Report Date 10/22/2019
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received10/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberRFX058-130-08
Device LOT NumberA886891
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/15/2019
Was Device Evaluated By Manufacturer? No Answer Provided
Date Device Manufactured08/22/2019
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient TREATMENT DATA
Date Received: 10/23/2019 Patient Sequence Number: 1
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