MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY-DUO 16; CATHETER, PERCUTANEOUS

Model Number	MC162167S
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: patient diagnosed with davf.Physician decided to treat it with liquid embolic.Used guiding sheath and guide catheter respectively.Headway duo 167 taken as microcatheter and navigated into the davf over guidewire.While injecting the first vial of liquid embolic through headway duo167, physician observed that the liquid embolic is leaking out from the microcatheter.So, physician immediately took out the headway duo 167 microcatheter.Finally, physician took 2 vials of liquid embolic and embolized the davf through (non-mvi) microcatheter.All final dsa runs were clear and hence physician decided to stop the procedure.Case completion was satisfactory.There was no other intervention pertaining to the leak besides the microcatheter removal.Patient was extubated with all limbs moving and obeying all commands of treating physician.
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 stated to be available for return to the manufacturer for evaluation but has not yet been returned despite a device return attempt.Ongoing attempts will be made for the device return.The alleged product issue/event as described could not be confirmed.If the device is received at a later date, an investigation will be performed and a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Correction: corrected report type in section b from "adverse event" to "product problem".Items received for investigation: headway-duo 16 microcatheter.The microcatheter was returned with squid embolic visible in the hub and at the distal tip.No evidence of leaking or breaches in the lumen were observed along the length of the device; however, due to the occlusion of the squid embolic, the investigation could not perform any leak testing to further assess the alleged product issue.The investigation of the returned headway microcatheter found squid embolic occluding the hub and lumen.No evidence of leaking or breaches in the lumen were observed along the length of the device during the investigation; however, due to the occlusion of the squid embolic, the investigation could not perform any leak testing to further assess the alleged product issue.
Event or Problem Description
As reported: patient diagnosed with davf.Physician decided to treat it with liquid embolic.Used guiding sheath and guide catheter respectively.Headway duo 167 taken as microcatheter and navigated into the davf over guidewire.While injecting the first vial of liquid embolic through headway duo167, physician observed that the liquid embolic is leaking out from the microcatheter.So, physician immediately took out the headway duo 167 microcatheter.Finally, physician took 2 vials of liquid embolic and embolized the davf through (non-mvi) microcatheter.All final dsa runs were clear and hence physician decided to stop the procedure.Case completion was satisfactory.There was no other intervention pertaining to the leak besides the microcatheter removal.Patient was extubated with all limbs moving and obeying all commands of treating physician.Procedure: embolization with les.

• Brand Name: HEADWAY-DUO 16
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 20072497
• Report Number: 2032493-2024-00636
• Device Sequence Number: 11521784
• Product Code: DQY
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)240318(17)270228(10)0000551064
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 10/01/2024

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: Health Professional
• Device Model Number: MC162167S
• Device Lot Number: 0000551064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/30/2024
• Initial Report FDA Received Date: 08/26/2024
• Supplement Report FDA Received Date: 10/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/18/2024
• 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: DESTINATION 7F.; ENVOY 6F.; SQUID.; TRAXCESS GUIDEWIRE.
• Patient Age: 67 YR
• Patient Sex: Male