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

Model Number	MC172150SX
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation and a preliminary investigation was performed.The investigation is, however, still ongoing.The results will be communicated in a supplemental mdr when the investigation is completed.
Event or Problem Description
It was reported that a microcatheter experienced friction in its lumen while a stent was being advanced within it.The catheter and stent were removed together and the physician selected a new stent and catheter to complete the case.The patient's condition was reported to be "good." when a preliminary test was conducted on the catheter by the manufacturer, a stent advanced within it emerged from the catheter with the catheter's ptfe liner material on it.
Event or Problem Description
It was reported that a microcatheter experienced friction in its lumen while a stent was being advanced within it.The catheter and stent were removed together and the physician selected a new stent and catheter to complete the case.The patient's condition was reported to be "good." when a preliminary test was conducted on the catheter by the manufacturer, a stent advanced within it emerged from the catheter with the catheter's ptfe liner material on it.
Additional Manufacturer Narrative
Items returned for investigation: -lvis jr.Stent -lvis jr.Pusher -headway 17 microcatheter items not returned for investigation: -lvis jr.Introducer the lvis pusher was returned in the headway microcatheter.The stent was returned fully deployed.The microcatheter hub was returned intact.The proximal marker band was found to be detached.The pusher was removed from the microcatheter and was found to have ptfe and residual dried bodily fluids on the pusher body coil.The stent was loaded onto an in-house pusher with an in-house introducer and advanced into the returned microcatheter.The stent encountered resistance at the distal portion of the microcatheter during retraction and emerged from the lumen with scraped ptfe liner material.The reported complaint is non-verifiable.The investigation found the lvis pusher returned within the headway microcatheter lumen.The pusher was removed from the microcatheter and was found to have ptfe liner from the microcatheter lumen on the pusher body coil.The stent was advanced into the microcatheter for functional testing, and the stent encountered resistance at the distal portion of the microcatheter during retraction and deployed from the lumen with scraped ptfe liner.The damaged liner likely contributed to the resistance experienced during the investigation testing.However, the physical evaluation of the device could not identify the conditions or circumstances that led to the ptfe damage as the device inadvertently underwent e-beam sterilization, which is known to degrade ptfe.H11 - corrections made to d2 and d1.

• Brand Name: HEADWAY ADVANCED
• Common Device Name: CATHETER PERCUTANEOUS
• 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: 19094395
• Report Number: 2032493-2024-00296
• Device Sequence Number: 12579765
• Product Code: DQY
• UDI-Device Identifier: 00810170013751
• UDI-Public: (01)00810170013751(11)230403(17)260331(10)0000343504
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K101542
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2024

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: 03/31/2026
• Device Model Number: MC172150SX
• Device Lot Number: 0000343504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/12/2024
• Supplement Report FDA Received Date: 06/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/03/2023
• 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 Sex: Unknown