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

Model Number MC162167S

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

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

Event Date 11/27/2020

Event Type  Injury  

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 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.

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
• Type of Device: DIAGNOSTIC INTRAVASCULAR CATHETER
• MDR Report Key: 11061485
• MDR Text Key: 223363534
• Report Number: 2032493-2020-00387
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 00810170014413
• UDI-Public: (01)00810170014413(11)200602(17)230531(10)200602554
• Combination Product (y/n): N
• PMA/PMN Number: K120917
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 11/30/2020
• Initial Date FDA Received: 12/22/2020
• Supplement Dates Manufacturer Received: 12/14/2020
• Supplement Dates FDA Received: 01/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/02/2020
• 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 Outcome(s): Required Intervention
• Patient Age: 52 YR