MAUDE Adverse Event Report: CONCENTRIC MEDICAL MC18L; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90044

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Death (1802); Hemorrhage/Bleeding (1888); Perforation (2001)

Event Date 02/25/2012

Event Type  Death  

Manufacturer Narrative

The subject device was disposed in the hospital.

Event Description

It was reported that during mechanical thrombectomy for the atherothrombosis at the left internal carotid artery, when the microcatheter (subject device) was advanced in the middle cerebral artery "the displaced the m1 vessel running.Therefore, in penetrating branches, the intracranial hemorrhage occurred by perforation caused by the microcatheter." no additional treatment was done and it was reported that the patient died approximately 3 months later.No further information is available.

Manufacturer Narrative

Death date changed to (b)(6) 2012.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, death,hemorrhage and vessel perforation are known risks associated with such procedures and noted as such in the directions for use (dfu).Therefore, a root cause of anticipated procedural complication has been assigned to the event.

Event Description

It was reported that during mechanical thrombectomy for the atherothrombosis at the left internal carotid artery, when the microcatheter (subject device) was advanced in the middle cerebral artery "the displaced the m1 vessel running.Therefore, in penetrating branches, the intracranial hemorrhage occurred by perforation caused by the microcatheter." no additional treatment was done and it was reported that the patient died approximately 3 months later.No further information is available.

Manufacturer Narrative

Corrected: death date: (b)(6) 2012.Lot number: unknown.

Event Description

It was reported that during mechanical thrombectomy for the atherothrombosis at the left internal carotid artery, when the microcatheter (subject device) was advanced in the middle cerebral artery "the displaced the m1 vessel running.Therefore, in penetrating branches, the intracranial hemorrhage occurred by perforation caused by the microcatheter." no additional treatment was done and it was reported that the patient died approximately 3 months later.No further information is available.

• Brand Name: MC18L
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• 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: 5336350
• MDR Text Key: 34735551
• Report Number: 0002954917-2015-00162
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K072796
• 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

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90044
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2015
• Initial Date FDA Received: 12/30/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/25/2016; 01/11/2016
• 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: 78 YR