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 Problem Vasoconstriction (2126)

Event Date 01/12/2012

Event Type  Injury  

Manufacturer Narrative

The subject device was disposed of at the hospital.

Event Description

It was reported that during the procedure after the balloon guide catheter (subject device) was placed in the left internal carotid artery, a spasm occurred near the tip of the device.Perdipine was administered for the spasm and it was improved.No further information is available.

• 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: 5336354
• MDR Text Key: 34737113
• Report Number: 0002954917-2015-00161
• 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
• 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: 12/07/2015
• 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; Required Intervention
• Patient Age: 38 YR