MAUDE Adverse Event Report: SEQUENT MEDICAL, INC VIA 21 MICROCATHETER

Model Number	FGA21154-01
Medical Device Problem Code	Unintended Movement (3026)
Health Effect - Clinical Codes	Hemorrhage, Subarachnoid (1893); Rupture (2208)
Date of Event	03/25/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history records indicated the lot met all release criteria.A lot history trending review was performed and there were no similar complaints for this lot number.The device was not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that during treatment for a basilar artery apex aneurysm, a 6f neuromax guiding sheath and a sofia catheter were used together with the via 21 microcatheter.After initial placement of the catheters, there was a pause in fluoroscopy and upon resuming fluoro, digital road mapping images demonstrated movement of the via catheter.Subsequent angiography demonstrated contrast extravasation from the dome of the aneurysm with resulting subarachnoid hemorrhage.Heparin was reversed and the via 21 was removed and replaced with an sl-10 microcatheter, and an occlusion balloon was positioned in the basilar artery to prevent blood flow to the aneurysm.Embolization coils were then deployed in the aneurysm and subsequent angiography confirmed that bleeding had stopped.An external ventricular drain (evd) was inserted to relieve/monitor intracranial pressures.It was reported that patient had no stroke, but had significant edema in the brain.The patient was taken to the icu and has been kept heavily sedated since the procedure to prevent patient movement and brain swelling.

• Brand Name: VIA 21 MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): SEQUENT MEDICAL, INC; 11 a columbia; aliso viejo CA 92656
• MDR Report Key: 8542393
• Report Number: 2032493-2019-00102
• Device Sequence Number: 19440896
• Product Code: OPR
• UDI-Device Identifier: 00851566003918
• UDI-Public: (01)00851566003918(11)190211(17)200331(10)19021106
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P170032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/25/2019

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?: Yes
• Operator of Device: Other
• Device Expiration Date: 03/31/2020
• Device Model Number: FGA21154-01
• Device Catalogue Number: FGA21154-01
• Device Lot Number: 19021106
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 61 YR