MAUDE Adverse Event Report: MICROVENTION, INC. HEADWAY 21+; CATHETER PERCUTANEOUS

Model Number	MC212156S
Medical Device Problem Codes	Material Protrusion/Extrusion (2979); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the patient was being treated for an anterior communicating (acom) artery aneurysm.The planned technique was an h-stent construct with 2 flow diverting stents.1 fred x going from right a2 ¿ a1 and 1 x silk vista baby on left a2- a1.The silk vista baby was able to be implanted successfully through a headway 17.Despite the patient anatomy being quite challenging around the arch, and even more challenging around the targeted site, the physician continually experienced excessive forces and complained of the concerned headway 21 microcatheter continually skipping.Access to the treatment site was quite tortuous and challenging and the physician was unable to re-access the location.The physician originally decided to stop the procedure on safety grounds after about 4 hours, with the intention of changing to surgical approach.Subsequently decided to try an endovascular approach again in approximately 6 weeks time.The patient is fine and there has been no clinical sequelae from this case.
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.The device has been returned to the manufacturer and its evaluation is pending.The investigation is ongoing.Upon completion of the investigation, a supplemental mdr will be submitted.
Additional Manufacturer Narrative
Additional information has been received indicating, the case was attempted again on (b)(6) 2025 using other devices, including a via 17 and headway 17 catheters.The physicians were again unable to gain access.The patient remains well and has been referred for neurosurgical review.Intra-op images were not available.Investigation conclusion: the investigation of the returned microcatheter found no damage along the surface of the device; however, an in-house guidewire encountered resistance during advancement testing, which is consistent with the resistance described in the reported event.Further investigation found the proximal end of the microcatheter shaft to exhibit incomplete flaring with exposed braid at the hub transition, which is consistent with the resistance experienced during the investigation.The physical evaluation of the device could not identify the exact conditions or circumstances that led to the flaring issue, but this condition is consistent with a deviation in the manufacturing process.Procedural images were unavailable to assess the alleged unexpected microcatheter movement; however, this behavior is consistent with difficulty advancing other devices through the lumen.The catheter condition is consistent with a deviation in the manufacturing process and will be addressed per the quality system process.

• Brand Name: HEADWAY 21+
• 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: 21379767
• Report Number: 2032493-2025-00128
• Device Sequence Number: 12877204
• Product Code: DQY
• UDI-Device Identifier: 00812636020945
• UDI-Public: (01)00812636020945(11)240402(17)270331(10)0000560750
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K093160
• 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): 04/10/2025

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: Health Professional
• Device Model Number: MC212156S
• Device Lot Number: 0000560750
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2025
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: 03/23/2025
• Initial Report FDA Received Date: 02/13/2025
• Supplement Report FDA Received Date: 04/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: FRED X21 FLOW DIVERTER (MICROVENTION).; HEADWAY 17 CATHETER (MICROVENTION).; HEADWAY 17 MICROCATHETER (MICROVENTION).; SILK VISTA BABY STENT (BALT).; SOFIA MICROCATHETER (MICROVENTION).; VIA 17 MICROCATHETER (MICROVENTION).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 66 YR
• Patient Sex: Female