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

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.

• Brand Name: 8F BGC 95CM
• Type of Device: CATHETER, 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 Key: 5336721
• MDR Text Key: 34734487
• Report Number: 0002954917-2015-00171
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• PMA/PMN Number: K102657
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• 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 Received: 12/30/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90073
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Death; Other
• Patient Age: 70 YR