MAUDE Adverse Event Report: HEADWAY DUO MICROCATHETER; DIAGNOSTIC INTRAVASCULAR CATHETER

Model Number	MC162167S
Medical Device Problem Codes	Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A search for non-conformance 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 discarded and not returned to the manufacturer for evaluation; therefore, the alleged product issue cannot be confirmed.
Event or Problem Description
It was reported that during an embolization procedure using the onyx liquid embolic, the microcatheter was captured in solidified embolic and separated as it was being removed from the onyx construct.The separated remnant of the microcatheter was aspirated from the patient without incident.There was no reported patient injury.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• MDR Report Key: 10795732
• Report Number: 2032493-2020-00316
• Device Sequence Number: 1074446
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)200526(17)230430(10)20052611H
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K120917
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/05/2020

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: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: MC162167S
• Device Catalogue Number: MC162167S
• Device Lot Number: 20052611H
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2020
• Initial Report FDA Received Date: 11/05/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/26/2020
• 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: Required Intervention
• Patient Age: 56 YR
• Patient Weight: 80