MAUDE Adverse Event Report: CONCENTRIC MEDICAL TREVO PRO 18RO MICROCATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number 90238

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

Patient Problem Vasoconstriction (2126)

Event Date 10/06/2016

Event Type  Injury  

Manufacturer Narrative

The subject was disposed of by the user facility.

Event Description

It was reported that during a thrombectomy procedure, a vasospasm occurred when the balloon guide catheter was placed and after the microcatheter (subject device) was being advanced.The vessel spasm was resolved with medication.The user facility indicated that in spite of the event, the procedure was successfully completed.At 30 days follow up, the patient was reported to have a modified rankin scale of 2.The reported event was assessed as highly related to the procedure and possibly related to the device(s).No further information is available.

Event Description

It was reported that during a thrombectomy procedure, a vasospasm occurred when the balloon guide catheter was placed and after the microcatheter (subject device) was being advanced.The vessel spasm was resolved with medication.The user facility indicated that in spite of the event, the procedure was successfully completed.At 30 days follow up, the patient was reported to have a modified rankin scale of 2.The reported event was assessed as highly related to the procedure and possibly related to the device(s).No further information is available.

Manufacturer Narrative

The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.Vasospasm is a known risk associated with endovascular procedures and is noted as such in the device directions for use (dfu); therefore, anticipated in nature.However, because the device was not returned the exact cause for the difficulties encountered with the device cannot be definitively determined.

Event Description

It was reported that during a thrombectomy procedure, a vasospasm occurred when the balloon guide catheter was placed and after the microcatheter (subject device) was being advanced.The vessel spasm was resolved with medication.The user facility indicated that in spite of the event, the procedure was successfully completed.At 30 days follow up, the patient was reported to have a modified rankin scale of 2.The reported event was assessed as highly related to the procedure and possibly related to the device(s).No further information is available.

• Brand Name: TREVO PRO 18RO MICROCATHETER
• 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: tara lopez ; 301 east evelyn; mountain view, CA 94041 ; 6509382100
• MDR Report Key: 6168426
• MDR Text Key: 62186365
• Report Number: 0002954917-2016-00169
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: ES
• PMA/PMN Number: K113260
• 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: 02/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2017
• Device Catalogue Number: 90238
• Device Lot Number: 38925
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2015
• 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: BALLOON GUIDE CATHETER (CONCENTRIC)
• Patient Outcome(s): Required Intervention
• Patient Age: 39 YR