MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY DUO MICROCATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	MC162167S
Medical Device Problem Codes	Entrapment of Device (1212); Material Separation (1562)
Health Effect - Clinical Codes	Hematoma (1884); Intracranial Hemorrhage (1891); Loss of consciousness (2418); Ischemia Stroke (4418)
Date of Event	10/01/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that phil liquid embolic was used to treat an avm and was delivered through a headway duo microcatheter after the microcatheter was placed in the avm feeder artery.It was reported that there was initially some resistance during injection.The phil was allowed to reflux over the catheter tip 3cm.The physician attempted to remove the headway duo microcatheter after 3 minutes had passed since the phil was injected.Resistance was encountered during removal of the microcatheter and the physician applied resistance three times in order to remove it.It was first thought that the microcatheter was removed because the catheter had come out of the femoral sheath, but angiography confirmed that the duo had separated and the distal portion was left in the patient down to the carotid artery.The patient was conscious right after embolization but angiography revealed a small bleed in the area of embolization.The physician then took follow-up angiography every two hours and found the bleeding worsened.The patient was taken to emergency surgery around midnight of oct.1st.Ventriculostomy was performed to control intracranial pressure.Hematoma removal surgery was performed on the area of the brain bleed on oct.2nd.Additional surgery was performed on october 4th to remove the piece of the catheter.Cranial infarction occurred on the left occipital area where the embolization procedure took place.In follow up angiography, it seemed that were some signs of cranial infraction in the left mca area.A second round of anti-thrombotic agent were given as a post-operative medication to address the possible cranial infarction.The physician found signs of cranial infractions on the right side of the brain even though no embolization procedures took place there.The patient is unconscious and is in a stupor state.(ref uf medwatch report# 2032493-2021-00447).
Additional Manufacturer Narrative
A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded at the user facility and not returned to the manufacturer for evaluation.Angiographic images and additional information was provided by the physician and the investigation is currently ongoing.The instructions for use (ifu) identifies intracerebral/intracranial hemorrhage and stroke as potential complications associated with use of the device.
Additional Manufacturer Narrative
The investigation of the angiographic images and additional information (physician's notes) was completed.The images provided show: pre procedural l ica ap and lateral: there is embolic material in the residual avm, meaning it has been embolized before as noted by the physician.The roadmap image obtained during the procedure show a cast of phil in the feeding artery (anterior cerebral artery) and the nidus; the duo is in the vessel and there is about 3 cm of reflux over the tip (according to the physician's note).The entire aca is straightened by the pulling force applied to the duo.The post-procedure angio images (head and neck, subtracted and not subtracted) show the duo from the tip embedded in the phil in the aca feeder to the low neck.There are no radiographs showing where the broken end of the duo is located.The aca is not stretched anymore.The post procedure ct scan shows a left frontal acute intraparenchymal hemorrhage, subarachnoid blood in the left sylvian fissure and blood on the surface of the left tentorium.Examination of the provided device image shows a distal section from 0cm to approximately 2.0cm from the distal tip.At the 2.0cm mark the catheter seems to be broken.Without the return and physical evaluation of the device, the investigation is unable to determine the root cause of the catheter separation; however, based on the review of the provided fluoroscopic images, the phil reflux appears to be 3cm, which exceeds the maximum allowable reflux as defined in the ifu.The investigation determined that this is likely the primary contributing factor to the reported event.(b5) - remove reference to medwatch report# 2032493-2021-00447.That report is not related to this one.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 12756108
• Report Number: 2032493-2021-00428
• Device Sequence Number: 3133421
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)210720(17)240630(10)21072053A
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/05/2021

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: Health Professional
• Device Expiration Date: 06/30/2024
• Device Model Number: MC162167S
• Device Catalogue Number: MC162167S
• Device Lot Number: 21072053A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 10/31/2021
• Initial Report FDA Received Date: 11/07/2021
• Supplement Report FDA Received Date: 11/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PHIL LIQUID EMBOLIC.
• Outcome Attributed to Adverse Event: Other; Disability; Required Intervention; Hospitalization
• Patient Sex: Male