MAUDE Adverse Event Report: CONCENTRIC MEDICAL 8F BGC 80CM; PERCUTANEOUS CATHETER

Catalog Number 90076

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

Patient Problem Intracranial Hemorrhage (1891)

Event Date 05/09/2016

Event Type  Injury  

Manufacturer Narrative

The subject device was disposed of at the hospital.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment.During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as self-resolved.The patient was discharged home approximately three days later.The event was reported to be related to the procedure and unknown if related to the device.

Manufacturer Narrative

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, hemorrhage is a known risk associated with such procedures and noted as such in the directions for use (dfu).Therefore, an assignable cause of anticipated procedural complication has been assigned to the event.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment.During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as self-resolved.The patient was discharged home approximately three days later.The event was reported to be related to the procedure and unknown if related to the device.

Event Description

It was reported that the patient underwent a mechanical thrombectomy procedure for a clot located at the right middle cerebral artery m1 segment.During the end of the procedure the patient experienced a non-symptomatic intracranial hemorrhage.No treatment was required and the outcome was reported as self-resolved.The patient was discharged home approximately three days later.The event was reported to be related to the procedure and unknown if related to the device.

• Brand Name: 8F BGC 80CM
• Type of Device: PERCUTANEOUS CATHETER
• 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: tara lopez ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 5802952
• MDR Text Key: 49840739
• Report Number: 0002954917-2016-00109
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153729
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: study
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 06/20/2016

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: 90076
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/31/2016; 11/22/2016
• 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
• Treatment: TREVO XP PROVUE RETRIEVER (CONCENTRIC)
• Patient Outcome(s): Other
• Patient Age: 87 YR