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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL 8F BGC 80CM PERCUTANEOUS CATHETER

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CONCENTRIC MEDICAL 8F BGC 80CM PERCUTANEOUS CATHETER Back to Search Results
Catalog Number 90076
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Intracranial Hemorrhage (1891)
Event Date 05/09/2016
Event Type  Injury  
Manufacturer Narrative
The subject device was disposed of at the hospital.
 
Event Description
It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment. During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage. No treatment was required and the outcome was reported as self-resolved. The patient was discharged home approximately three days later. The event was reported to be related to the procedure and unknown if related to the device.
 
Manufacturer Narrative
The device history record review was unable to be performed as the lot number of the device was not reported. The subject device is not available; therefore analysis cannot be performed. From the information available, there is no indication that the reported event is related to product specifications nonconformance or misuse. There is also no indication that the subject device malfunctioned. However, hemorrhage is a known risk associated with such procedures and noted as such in the directions for use (dfu). Therefore, an assignable cause of anticipated procedural complication has been assigned to the event.
 
Event Description
It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment. During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage. No treatment was required and the outcome was reported as self-resolved. The patient was discharged home approximately three days later. The event was reported to be related to the procedure and unknown if related to the device.
 
Event Description
It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment. During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage. No treatment was required and the outcome was reported as self-resolved. The patient was discharged home approximately three days later. The event was reported to be related to the procedure and unknown if related to the device.
 
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Brand Name8F BGC 80CM
Type of DevicePERCUTANEOUS CATHETER
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
tara lopez
301 east evelyn
mountain view, CA 94041
6509382100
MDR Report Key5802952
MDR Text Key49840739
Report Number0002954917-2016-00109
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153729
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type study
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 06/20/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number90076
Device Lot NumberUNKNOWN
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 Received11/07/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 07/19/2016 Patient Sequence Number: 1
Treatment
TREVO XP PROVUE RETRIEVER (CONCENTRIC)
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