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 Thromboembolism (2654)

Event Date 08/19/2012

Event Type  Injury  

Manufacturer Narrative

The device was disposed in the hospital.

Event Description

It was reported in the post marketing surveillance (pms) that the patient presented with a left middle cerebral artery (mca) cardiogenic occlusion.There were difficulties encountered while a balloon guide catheter (subject device) was being advanced to the target lesion.The subject device was placed at the target lesion; however, after the device placement, embolization to a new distal portion of the left anterior cerebral artery (aca) occurred.During following mechanical thrombectomy both the original mca and the new aca clots were removed.The physician stated that the cause of the aca embolus cannot be definitely determined.The embolus could be related to a pre-existing atrial fibrillation or to the use of the subject balloon guide catheter.

Manufacturer Narrative

The device was not available for analysis.From the information provided there was no indication that the device was not used as in accordance with the labeling or that this caused or contributed to the reported event.Thromboembolism is a known and anticipated complication to these types of procedures and is noted in the labeling.Therefore, it was determined that the reported event was an anticipated procedural complication.

Event Description

It was reported in the post marketing surveillance (pms) that the patient presented with a left middle cerebral artery (mca) cardiogenic occlusion.There were difficulties encountered while a balloon guide catheter (subject device) was being advanced to the target lesion.The subject device was placed at the target lesion; however, after the device placement, embolization to a new distal portion of the left anterior cerebral artery (aca) occurred.During following mechanical thrombectomy both the original mca and the new aca clots were removed.The physician stated that the cause of the aca embolus cannot be definitely determined.The embolus could be related to a pre-existing atrial fibrillation or to the use of the subject balloon guide catheter.

• 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: 5043056
• MDR Text Key: 24632366
• Report Number: 0002954917-2015-00074
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• 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: 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: 94 YR