MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER

Model Number	MC162167S
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Codes	Infarction, Cerebral (1771); Death (1802); Thrombus (2101)
Date of Event	10/27/2017
Type of Reportable Event	Death
Additional Manufacturer Narrative
The lot number was provided.A review of the device history records indicated the lot met all the release criteria.A lot history trending review was performed and there were no similar complaints reported for this lot number.The device was discarded at the user facility; therefore, a product analysis could not be performed.The instructions for use (ifu) identifies death and thrombus formation as potential complications associated with use of the device.
Event or Problem Description
It was reported that the patient presented with a headache and was neurologically intact.A ct and subsequent angiogram confirmed a ruptured left pica avm.The decision was made to embolize the avm with onyx.Treatment was performed on friday, (b)(6) 2017.The patient was reported to have been anticoagulated.Access to the avm was easily established from the left vertebral artery using a 6f shuttle guiding sheath, a sofia 5f catheter, and a 167cm headway duo microcatheter.The onyx was delivered through the headway without complication, which resulted in complete embolization of the avm; however, the headway was unable to be removed from the cast of the onyx.A technique to gently ease the headway from the onyx was employed by applying a little tension to the headway and retracting it approximately 1 cm; the touhy was then tightened around the headway for approximately 3 minutes.Afterward, the headway was retracted another 1 cm for another minute, the touhy was tightened, and the headway finally freed from the onyx.Upon removal of the headway, the last cm of the distal end was missing.The tip was not visible under fluoroscopy, and it was suspected to be encased in the onyx.There appeared to be no clinical effects and the procedure was completed.The patient was taken to post-op recovery; however, an hour later, the patient's condition began to decline, another ct was performed, which confirmed a basilar infarct.Another interventional procedure was performed, and the angiogram revealed a thrombotic occlusion at the basilar artery tip.Attempts were made to retrieve the clot with aspiration.Closer examination of the angiogram revealed the presence of some "tangling" or "bunched-up" very fine wire where the pica comes back into the vertebral artery.The patient was reported to have died two days later, on (b)(6) 2017.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: MICROCATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7077371
• Report Number: 2032493-2017-00309
• Device Sequence Number: 11016374
• Product Code: DQY
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)170711(17)200630(10)170711131
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K083343
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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
• Operator of Device: Other
• Device Expiration Date: 06/30/2020
• Device Model Number: MC162167S
• Device Lot Number: 170711131
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/01/2017
• Initial Report FDA Received Date: 12/01/2017
• 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: Death
• Patient Age: 64 YR