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 Hemorrhage, Subarachnoid (1893); Perforation of Vessels (2135)

Event Date 03/24/2013

Event Type  Injury  

Manufacturer Narrative

Device not available to the manufacturer.

Event Description

It was reported that during a thrombectomy procedure to revascularize the left internal carotid artery (ica), the microcatheter perforated the vessel and hemorrhage occurred.No additional treatment was administered on the patient.The procedure was completed and the patient reportedly recovered.No further information is available.

Manufacturer Narrative

The subject device is not available; therefore, analysis cannot be performed.Hemorrhage and perforation are known risks associated with endovascular procedures and are noted as such in the directions for use (dfu).Therefore, a root cause of anticipated procedural complications has been assigned to this event.

Event Description

It was reported that during a thrombectomy procedure to revascularize the left internal carotid artery (ica), the microcatheter perforated the vessel and hemorrhage occurred.No additional treatment was administered on the patient.The procedure was completed and the patient reportedly recovered.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: bertha paulo ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 5010879
• MDR Text Key: 23320389
• Report Number: 0002954917-2015-00066
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 90044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2015
• 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): Other
• Patient Age: 83 YR