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

Model Number MV-MS166D

Device Problem Flaked (1246)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/08/2022

Event Type  malfunction  

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.It was stated that the device is available for evaluation, but it has not yet been returned to the manufacturer.The alleged issue could not yet be confirmed.If the device is received, an investigation will be performed and a supplemental mdr will be submitted.

Event Description

It was reported that after the headway microcatheter was used to treat an aneurysm, it was immersed in saline to clear off the blood from the device, and a fragment of unknown origin was observed in the saline tray.A competitor's microcatheter was used to complete the procedure.There was no reported injury or health damage to the patient.

Manufacturer Narrative

The investigation of the returned catheter found no damage, defects, or other anomalies along the surface of the device.The unknown material returned with the catheter, although green in color, showed to be a different shade of green and had a different texture than that of the headway duo microcatheter.The only green material color used on the headway duo device is for the outer layer which is of a different green color than the specimen.The guidewire used in the procedure was not evaluated as a part of this evaluation, so the investigation could not determine if it had caused or contributed to the reported complaint; however, the guidewire was stated to also be green in color as per the event description and therefore, the unknown material may have originated from the guidewire.

• Brand Name: HEADWAY-DUO 16
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MICROVENTION INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terrenace callahan ; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 15115596
• MDR Text Key: 302426129
• Report Number: 2032493-2022-00290
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 04987350870292
• UDI-Public: (01)04987350870292(11)220207(17)250131(10)0000154983
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-MS166D
• Device Lot Number: 0000154983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1