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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCENTRIC MEDICAL 8F BGC 95CM CATHETER, PERCUTANEOUS

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CONCENTRIC MEDICAL 8F BGC 95CM CATHETER, PERCUTANEOUS Back to Search Results
Catalog Number 90073
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Vascular Dissection (3160)
Event Date 12/21/2012
Event Type  Death  
Manufacturer Narrative

The subject device is not available.

 
Event Description

It was reported in a post market surveillance report that the clot was located in the left m2. During clot removal with the subject device, the patient suddenly got up and due to the motion, the left internal carotid artery got dissected. No treatment was administered as there were no carotid stents in the hospital. The tici score was 1. The patient passed away.

 
Manufacturer Narrative

The device history record review could not be performed because the lot number of the device is not known. The device was not returned for analysis therefore visual inspection and functional testing could not 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. Vessel dissection and patient death are known and anticipated complications to these types of procedures and are noted in the labeling. Therefore, it was determined that the reported event was an anticipated procedural complication.

 
Event Description

It was reported in a post market surveillance report that the clot was located in the left m2. During clot removal with the subject device, the patient suddenly got up and due to the motion, the left internal carotid artery got dissected. No treatment was administered as there were no carotid stents in the hospital. The tici score was 1. The patient passed away.

 
Manufacturer Narrative

This complaint was determined to be a duplicate of an earlier complaint. Mdr 0002954917-2013-00014 was filed for the earlier complaint. Therefore, a retraction mdr is being submitted for this complaint.

 
Event Description

It was reported in a post market surveillance report that the clot was located in the left m2. During clot removal with the subject device, the patient suddenly got up and due to the motion, the left internal carotid artery got dissected. No treatment was administered as there were no carotid stents in the hospital. The tici score was 1. The patient passed away.

 
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Brand Name8F BGC 95CM
Type of DeviceCATHETER, PERCUTANEOUS
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
sanda dracic
301 east evelyn
mountain view, CA 94041
6509382100
MDR Report Key5336721
MDR Text Key34734487
Report Number0002954917-2015-00171
Device Sequence Number1
Product Code DQY
Combination Product (Y/N)N
PMA/PMN NumberK102657
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 12/07/2015
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/30/2015
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number90073
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 Received05/03/2016
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: 12/30/2015 Patient Sequence Number: 1
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