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	11/27/2020
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 returned to the manufacturer for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that during an avm embolization with a liquid embolic, the catheter became entrapped in the embolic and detached in the patient during removal.The catheter was surgically removed.The patient is currently doing well and there was no reported sequela.
Additional Manufacturer Narrative
Multiple points of damaged coil, ptfe extrusion, and torn lumen were found on the device as received.The conditions or circumstances that led to the damage could not be determined, but the damage is consistent with the device experiencing forces over specification.The distal end of the microcatheter also appeared to have embolic residue on the outer surface, which is consistent with the alleged product issue.

• Brand Name: HEADWAY DUO MICROCATHETER
• Common Device Name: DIAGNOSTIC INTRAVASCULAR CATHETER
• MDR Report Key: 11061485
• Report Number: 2032493-2020-00387
• Device Sequence Number: 2691628
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)200602(17)230531(10)200602554
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/13/2020

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: 05/31/2023
• Device Model Number: MC162167S
• Device Catalogue Number: MC162167S
• Device Lot Number: 200602554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 01/13/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2020
• 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: 52 YR