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

Model Number	MC162156S
Medical Device Problem Codes	Entrapment of Device (1212); Fracture (1260)
Health Effect - Clinical Codes	Brain Injury (2219); Intracranial Pressure Increased (4586)
Date of Event	07/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance's 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 analysis, but it has not yet been returned.Supplemental imaging and medical notes are being sought.A supplemental report will be submitted when the device and more information is obtained and analyzed.
Event or Problem Description
It was reported that an mma embolization was being performed with liquid embolic.Upon delivering the embolic to the treatment zone, the physician tried to removed the catheter and could not as the glue adhered to the tip of the headway duo microcatheter.After pulling hard, the catheter fractured and the distal portion remained in the patient.The proximal remainder was removed.It was reported that intervention was performed.Two days post procedure, the patient returned to the hospital with a midline shift and is now reported to be in a deteriorating condition as the brain is now swollen and has a buildup of pressure.
Event or Problem Description
It was reported that an mma embolization was being performed with liquid embolic.Upon delivering the embolic to the treatment zone, the physician tried to removed the catheter and could not as the glue adhered to the tip of the headway duo microcatheter.After pulling hard, the catheter fractured and the distal portion remained in the patient.The proximal remainder was removed.It was reported that intervention was performed.Two days post procedure, the patient returned to the hospital with a midline shift and is now reported to be in a deteriorating condition as the brain is now swollen and has a buildup of pressure.Updated information was received from the physician.The intervention that was performed during the procedure was an attempted snare of the proximal portion of the catheter with a gooseneck snare.The patient was reported to now be doing well overall.The physician did not consider any of the clinical consequences attributable to the catheter to be appreciable.The procedure was a elective mma embolization for a stable subdural hematoma.
Additional Manufacturer Narrative
Additional information was received via email from the physician.Updates were made to b5 (the intervention that was performed during the procedure was an attempted snare of the proximal portion of the catheter with a gooseneck snare.The patient was reported to now be doing well overall.The physician did not consider any of the clinical consequences attributable to the catheter to be appreciable.The procedure was a elective mma embolization for a stable subdural hematoma.).The device was received - d10 was updated.The physician stated that imaging was not available.Device evaluation: items returned for investigation: headway-duo (b)(4) items not returned for investigation: n/a the device was returned with residual fluid and embolic in the hub.The distal end of the microcatheter was broken and showed signs of stretching.The investigation found the catheter returned with residual liquid embolic in the hub and the distal end broken with signs of stretching at the site of the break, which is consistent with the condition described in the reported event.The physical evaluation of the device could not determine the exact conditions or circumstances that led to the distal tip break, but this damage is consistent with the distal tip becoming entrapped in an embolic substance followed by retraction forces that exceeded the tensile strength of the microcatheter.

• Brand Name: HEADWAY DUO
• 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: 19801754
• Report Number: 2032493-2024-00562
• Device Sequence Number: 12859214
• Product Code: DQY
• UDI-Device Identifier: 00810170014345
• UDI-Public: 00810170014345
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2024

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: MC162156S
• Device Catalogue Number: MC162156S
• Device Lot Number: 0000465028
• 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: 07/05/2024
• Supplement Date Received by Manufacturer: 07/05/2024
• Initial Report FDA Received Date: 07/22/2024
• Supplement Report FDA Received Date: 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/22/2023
• 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
• Outcome Attributed to Adverse Event: Other; Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male