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

Model Number MC162167S

Device Problems Break (1069); Material Separation (1562)

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

Event Date 08/10/2023

Event Type  malfunction  

Event Description

It was reported that the physician was doing a face arteriovenous malformation (avm case) using a liquid embolic.As the physician removed the microcatheter after approximately 15 minutes of use, he realized that the outer tip of the microcatheter was missing.Using an ultrasound post procedure, as the tip was not visible on the angiogram, the physician confirmed that the tip of the microcatheter was found hanging on the wall of the carotid.No intervention was done post procedure, and the tip was left inside the patient.There was no reported injury to the patient and was reported to be good.

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 reported to be available for return to the manufacturer for evaluation but has not yet been returned.The reported 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.

Manufacturer Narrative

The reported complaint is confirmed as the condition of the returned device is consistent with the reported complaint.The cause of the broken microcatheter could not be determined from the investigation but is consistent with experiencing forces over specification during the procedure.

Event Description

See h10.

• Brand Name: HEADWAY-DUO 16
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• 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: 17858154
• MDR Text Key: 325087180
• Report Number: 2032493-2023-00971
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)220518(17)250430(10)0000194915
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC162167S
• Device Lot Number: 0000194915
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/18/2022
• 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
• Patient Sex: Female