MAUDE Adverse Event Report: ANGIODYNAMICS VASCULAR GUIDEWIRE; VASCULAR GUIDEWIRE, NITINOL W/ HYDROPHILIC COATING, STRAIGHT, RADIOPAQUE TIP

Catalog Number	45747
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A territory manager reported an end user experienced a procedure in which they had an issue using a guidewires, nitinol.018x145cm, tungsten coil, hydrophilic kit.During the procedure, it was reported the tip of the guidewire detached inside the patient.The tip was successfully retrieved; however, the procedure was not continued.The patient did not experience any adverse effects or harm due to this incident.
Additional Manufacturer Narrative
The reported device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of guidewire tip detached inside the patient was not confirmed; the guidewire sample was not returned.Without receiving the complaint sample for evaluation, a definitive root cause cannot be determined.Potential root cause for this type of guidewire failure mode is the end user pulling the guidewire back against the needle if resistance to advancement is observed.Dhr review of the indicated packaging lot showed no device non-conformance at the time of device distribution.The guidewire in question is a finished packaged good that is purchased from heraeus medical.Heraeus medical was made aware of this reported event via fyi scar00004741.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Labeling review: dfu provided with this guidewire device contains the following statements: directions: insert the guidewire into the needle and advance the guidewire to the targeted location.The guidewire tip can be visualized under fluoroscopy during insertion.Once the guidewire is inserted, remove the needle.Do not advance the guidewire against resistance until the cause of the resistance has been determined.Cautions: do not advance the vascular guidewire against resistance until the cause of the resistance has been determined.Excessive force against resistance may result in damage to the guidewire and catheter or vessel perforation.Navilyst medical, inc.Does not recommend a particular technique for the use of this device.The steps contained in the preceding directions discuss the seldinger technique for percutaneous entry and are of information purposes only.Each physician should evaluate their appropriateness according to individual patient conditions and his or her medical training and experience.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).

• Brand Name: VASCULAR GUIDEWIRE
• Common Device Name: VASCULAR GUIDEWIRE, NITINOL W/ HYDROPHILIC COATING, STRAIGHT, RADIOPAQUE TIP
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16273419
• Report Number: 1317056-2023-00013
• Device Sequence Number: 7455392
• Product Code: DQX
• UDI-Device Identifier: H965457471
• UDI-Public: H965457471
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K070150
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/10/2023

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 Catalogue Number: 45747
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 05/04/2023
• Initial Report FDA Received Date: 01/31/2023
• Supplement Report FDA Received Date: 05/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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