MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 27+; ACCESS DEVICES

Model Number	MC272156S
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a thrombectomy on the m2 segment of the left medial artery, the catheter was torn off at the proximal end during the first pass.The catheter was able to be removed from the patient¿s body completely.The procedure was completed using a new catheter.The patient was reported to be ¿doing well¿ and that this event caused no injury.
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.The alleged product issue 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
Summary device evaluation: the catheter was received in three sections.Upon visual inspection, it was found that all separated ends were flattened/kinked suggesting that the catheter was cut at these sections.Additional kinks and occlusion found during inspection suggest that the catheter had to be taken off by cutting it which resulted in three sections of the catheter.The physical evaluation of the device could not identify the conditions or circumstances that led to the catheter being pulled off by cutting it, but the additional damage found is consistent with the device experiencing forces over specification.

• Brand Name: HEADWAY 27+
• Common Device Name: ACCESS DEVICES
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 16705432
• Report Number: 2032493-2023-00652
• Device Sequence Number: 5669761
• Product Code: DQY
• UDI-Device Identifier: 00811425021385
• UDI-Public: (01)00811425021385(11)220901(17)250831(10)0000254294
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K142449
• 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,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: MC272156S
• Device Catalogue Number: MC272156S
• Device Lot Number: 0000254294
• 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: 03/23/2023
• Supplement Date Received by Manufacturer: 06/13/2023
• Initial Report FDA Received Date: 04/10/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2022
• 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
• Patient Age: 84 YR
• Patient Sex: Male