MAUDE Adverse Event Report: MICRO THERAPEUTICS, INC. DBA EV3 SUPPORT GUIDECATHETER; CATHETER, PERCUTANEOUS

Model Number RFX058-130-08

Device Problem Material Perforation (2205)

Patient Problem Hemorrhage, Cerebral (1889)

Event Date 10/15/2019

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported event will not be returned for evaluation as it was discarded; therefore, the event cause could not be determined.Correspondence has been sent out to the customer for images and additional information.Once correspondence has been received and the investigation has been completed, a supplemental report will be submitted.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received report that the medtronic guide catheter jumped up during embolization procedure causing the aneurysm to rupture.The physician was planning to use two medtronic flow divertor devices to treat two aneurysms.Prior to the event, the first medtronic flow divertor device was implanted in severely tortuous anatomy.Upon delivering the second flow divertor, the medtronic guide catheter was reported to ride up (due to the severely tortuous anatomy) and the proximal aneurysm ruptured.The flow divertor was placed.Bleeding was noted and an additional medtronic flow divertor was placed.The vessel was ballooned and inflated.An additional medtronic flow diverter was placed.The patient was sent to computed tomography (ct).Coils were placed the next day.The patient was reported to be alive and will possibly need to sacrifice the internal carotid artery (ica).The patient was undergoing embolization treatment of two aneurysms in the internal carotid artery (ica).The patient¿s vasculature was severe in tortuosity.Ancillary devices: synchro 2 guidewire, phenom 27 (ja19-086) microcatheter, navien.058 (a88691) guide catheter, shuffle 6f 90cm sheath.

• Brand Name: SUPPORT GUIDECATHETER
• Type of Device: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer (Section G): MICRO THERAPEUTICS, INC. DBA EV3; 9775 toledo way; irvine CA 92618
• Manufacturer Contact: katcha taylor ; 9775 toledo way; irvine, CA 92618 ; 9496801345
• MDR Report Key: 9222611
• MDR Text Key: 164115915
• Report Number: 2029214-2019-01061
• Device Sequence Number: 1
• Product Code: DQY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110055
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/21/2021
• Device Model Number: RFX058-130-08
• Device Lot Number: A886891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/15/2019
• Date Device Manufactured: 08/22/2019
• 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): Required Intervention; Disability
• Patient Age: 77 YR