MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 17 MICROCATHETER; PERCUTANEOUS CATHETER

Model Number	MC172150JX
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2021
Type of Reportable Event	Serious Injury
Additional 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.Investigation found kinks along the distal section of the catheter, and ptfe liner returned with the device, consistent with the alleged product issue.Built up ptfe liner in the catheter would cause a blockage, resulting in the inability to advance any ancillary devices.The physical evaluation of the device could not identify the conditions or circumstances that led to the damage, but the damage is consistent with the device experiencing forces over specification.
Event or Problem Description
It was reported that the coating of a headway catheter was peeling off and was occluding the inner lumen of the catheter.There was no reported patient injury or intervention.

• Brand Name: HEADWAY 17 MICROCATHETER
• Common Device Name: PERCUTANEOUS CATHETER
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 92656
• Manufacturer Contact: terence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 13007479
• Report Number: 2032493-2021-00486
• Device Sequence Number: 16575959
• Product Code: DQY
• UDI-Device Identifier: 00810170015519
• UDI-Public: (01)00810170015519(11)200609(17)230531(10)2006095A4
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K101542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2023
• Device Model Number: MC172150JX
• Device Catalogue Number: MC172150JX
• Device Lot Number: 2006095A4
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2021
• Initial Report FDA Received Date: 12/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/09/2020
• 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
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 66 KG