MAUDE Adverse Event Report: MICROVENTION, INC. TRAXCESS GUIDEWIRE; WIRE, GUIDE, CATHETER

Model Number	GW1420040
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Malfunction
Event or Problem Description
As reported: the inr team discovered, before the procedure, a thread like foreign body on the wire.The wire had not been in touch with anything before this was discovered.Patient status is good.
Additional Manufacturer Narrative
The device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.The alleged product issue/event as described could not be confirmed.
Event or Problem Description
As reported: the inr team discovered, before the procedure, a thread like foreign body on the wire.The wire had not been in touch with anything before this was discovered.Patient status is good.
Additional Manufacturer Narrative
Correction: brand name in d1 was corrected.Items returned: n/a.Since the actual sample was not returned, investigation of it could not be performed.100% visual inspection is performed to confirm that there is no foreign substance or dirt on the peel pack.Visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device¿s risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: history investigation of the product with the involved product code/lot#: no anomaly was found in the manufacturing record and the shipping inspection record.Complaint system review: history investigation of the product with the involved product code/lot#: no other similar report was found in the past.Ifu review: warnings: the guidewire is intended for single use only.Do not resterilize and/or reuse the device.After use, dispose in accordance with hospital and/or local government policy.Do not use if the packaging is breached or damaged.Inspect the guidewire prior to use for any irregularities or damage and discard if noted.The guidewire should be manipulated under fluoroscopic guidance.Do not advance or withdraw the guidewire when excessive resistance is met until the cause of resistance is determined.Observe the tip response when turning the guidewire and avoid turning in the same direction more than three times when the tip is stationary.Avoid kinking the tip of the guidewire, as damage to the guidewire might occur.Precautions: the guidewire has a lubricious surface and distal platinum coil section should be hydrated prior to use.Exercise care in handling the guidewire to reduce the chance of accidental damage.Do not expose the guidewire surface to organic solvents such as alcohol or medications, which might damage the guidewire coatings and/or cause the guidewire to loose lubricity.Potential complications include, but are not limited to: vessel or aneurysm perforation, vasospasm, hematoma at the site of entry, embolism, ischemia, intracerebral/intracranial hemorrhage, pseudoaneurysm, seizure, stroke, infection, death, and thrombus formation.Avoid repeated bending at the same point in order to avoid damage or separation of the guidewire.Take precaution when manipulating the guidewire in tortuous vasculature to avoid damage to the guidewire.Directions for use: carefully insert the distal section of the guidewire into the catheter and advance.A guidewire insertion tool may be used to facilitate insertion of the guidewire distal tip through a y-adapter and into the catheter hub.Advance the hydrophilic guidewire until the distal tip is near the distal end of the catheter.Gently tighten the hemostatic y-connector to maintain position.Slip the torque device over the proximal end of the guidewire to the desired location.Secure the torque device in place by tightening the rotating knob.The torque device may be repositioned by loosening and retightening the rotating knob.During navigation in the vasculature, loosen the hemostatic y-connector, advance and rotate the guidewire by rotating the torque device in either direction to facilitate vessel selection.To aid in catheter navigation , gently rotate the guidewire as it is advanced.Between uses, rinse the guidewire in a basin of heparinized saline and wipe it gently with sterile, wet gauze and place in a basin of heparinized saline or a flushed dispenser tube to keep the hydrophilic surface wet until use.Based on the investigation result, no anomaly was found in the manufacturing history record.Since the actual sample was not returned, it was not possible to clarify the cause of occurrence.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: TRAXCESS GUIDEWIRE
• Common Device Name: WIRE, GUIDE, CATHETER
• 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: 19280712
• Report Number: 2032493-2024-00371
• Device Sequence Number: 20758922
• Product Code: DQX
• UDI-Device Identifier: 00810170012280
• UDI-Public: (01)00810170012280(11)231107(17)261031(10)231107
• Combination Product (Y/N): N
• Initial Reporter Country: NO
• PMA/510(K) Number: K080863
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2024

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 Model Number: GW1420040
• Device Lot Number: 231107
• Was Device Available for Evaluation?: No
• 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: 04/23/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 05/09/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2023
• 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