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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL FLOWGATE2 8F X 95CM CATHETER, PECUTANEOUS

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CONCENTRIC MEDICAL FLOWGATE2 8F X 95CM CATHETER, PECUTANEOUS Back to Search Results
Catalog Number 90495
Device Problems Material Separation (1562); Device Markings/Labelling Problem (2911)
Patient Problems Embolism (1829); Device Embedded In Tissue or Plaque (3165)
Event Date 02/01/2017
Event Type  Injury  
Event Description

It was reported that during procedure, a balloon guide catheter (subject device) was placed in the internal carotid artery (ica) without issue. While bring up a microcatheter (stryker), the microcatheter hooked at the distal end of the subject device. Then a thrombectomy device (non-stryker device) was used. When the thrombectomy device was introduced, the radiopaque marker from the subject device detached. The radiopaque marker was observed in the middle cerebral artery-m2 segment. The procedure was completed with another thrombectomy device. There was no impact to the patient. According to the physician, the issue might be a fixing problem of the radiopaque marker as ¿the distal end of the balloon catheter has an unevenness¿.

 
Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications. Visual examination of the returned device revealed that the flowgate shaft was kinked just distal to the strain relief. The flowgate distal lumen was examined under magnification and it was observed that the distal tip marker had come off. The flowgate distal inner lumen was deformed. Functional testing was not performed because of the condition of the returned device. Information available indicated that no anomalies were noted to the balloon catheter prior to use and no resistance was felt during advancement/withdrawal of the balloon catheter. Based on the information available and analysis of the device, it is not clear what caused the reported and analyzed events. Therefore, the cause of the reported and analyzed events was undeterminable.

 
Event Description

It was reported that during procedure, a balloon guide catheter (subject device) was placed in the internal carotid artery (ica) without issue. While bring up a microcatheter (stryker), the microcatheter hooked at the distal end of the subject device. Then a thrombectomy device (non-stryker device) was used. When the thrombectomy device was introduced, the radiopaque marker from the subject device detached. The radiopaque marker was observed in the middle cerebral artery-m2 segment. The procedure was completed with another thrombectomy device. There was no impact to the patient. According to the physician, the issue might be a fixing problem of the radiopaque marker as "the distal end of the balloon catheter has an unevenness. ".

 
Manufacturer Narrative

(b)(4). Further review of the event by the safety team determined that the detached ro (radio opaque) marker did not create any embolism as reported previously. Therefore the device code for patient embolism is not applicable anymore. In addition product code updated to "material separation" instead of "device markings issue" in order to capture the detachment issue.

 
Event Description

It was reported that during procedure, a balloon guide catheter (subject device) was placed in the internal carotid artery (ica) without issue. While bring up a microcatheter (stryker), the microcatheter hooked at the distal end of the subject device. Then a thrombectomy device (non-stryker device) was used. When the thrombectomy device was introduced, the radiopaque marker from the subject device detached. The radiopaque marker was observed in the middle cerebral artery-m2 segment. The procedure was completed with another thrombectomy device. There was no impact to the patient. According to the physician, the issue might be a fixing problem of the radiopaque marker as ¿the distal end of the balloon catheter has an unevenness¿.

 
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Brand NameFLOWGATE2 8F X 95CM
Type of DeviceCATHETER, PECUTANEOUS
Manufacturer (Section D)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
Manufacturer (Section G)
CONCENTRIC MEDICAL
301 east evelyn
mountain view CA 94041
Manufacturer Contact
michael reddick
301 east evelyn
mountain view, CA 94041
6509382100
MDR Report Key6375018
MDR Text Key68963247
Report Number0002954917-2017-00015
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type HEALTH PROFESSIONAL
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/13/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/02/2017
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device EXPIRATION Date08/28/2018
Device Catalogue Number90495
Device LOT Number60757
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/21/2017
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/06/2017
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/24/2016
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: 03/02/2017 Patient Sequence Number: 1
Treatment
5 MAX ACE(PENUMBRA)
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