MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS; DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION

Model Number	45754
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
An angiodynamics territory manager reported an issue with a mini stick max 5f x 10cm std.018 ss/ss echo 2.75" pg.During a procedure, part of the micropuncture seared off, inside of the patient, during withdrawal.The fragment did not require the use of a snare to remove.The procedure was completed with another same device and there was no report of patient harm.Multiple attempts have been made to obtain further details; however, this has been unsuccessful.
Additional Manufacturer Narrative
The device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).
Additional Manufacturer Narrative
The customer's reported complaint description of guidewire tip detached was not confirmed since no complaint sample was returned.Without receiving the complaint sample for evaluation, we are unable to definitively determine a root cause for this incident.The guidewire device is supplied to angiodynamics by the supplier/manufacturer heraeus medical.(b)(4) was sent to heraeus for dhr review of the reported lot number.(b)(4)response stated that no deviations or nonconformances related to the [tip detached] event description were identified in the record review.There is no evidence to confirm the issue is due to the manufacturing process.This event is considered a non-manufacturing-related issue.A potential root cause for this type of guidewire tip detached within the vasculature failure mode is end user technique in pulling guidewire back against the needle tip bevel.This is cautioned against in device directions for use.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: direction for use (16600601-01) is provided with this mini-stick device.The failure mode of device fracture and embolization is cautioned as potential adverse event.No sample was returned for evaluation so it cannot be determined if device was used in a manner inconsistent with labeling.Adverse events guidewire shearing, fracture or embolization.Operational instructions 1.Prior to insertion, flush all components with saline or heparinized/saline.2.Gain percutaneous access with the 21 g (0.9 mm) vascular introducer needle.3.Advance the 0.018 inch (0.46 mm) guidewire through the needle.Caution: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire.4.Withdraw the introducer needle, leaving the 0.018 inch (0.46 mm) guidewire in place.5.Advance the coaxial assembly over the 0.018 inch (0.46 mm) guidewire.6.Simultaneously remove the dilator and 0.018 inch (0.46 mm) guidewire, while holding the sheath portion of the assembly in place.7.Advance a 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) guidewire into the sheath.8.Remove the sheath, leaving the 0.035 inch (0.89 mm) or 0.038 inch (0.97 mm) wire.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).
Additional Manufacturer Narrative
**udi related data quality updates only** the information in this report has been corrected to match the data submitted in global unique device identification database (gudid).Reference (b)(4).Corrections: d4: model #, udi.

• Brand Name: ANGIODYNAMICS
• Common Device Name: DILATOR, VESSEL, FOR PERCUTANEOUS CATHETERIZATION
• 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: 18255296
• Report Number: 1317056-2023-00169
• Device Sequence Number: 7108170
• Product Code: DRE
• UDI-Device Identifier: H965457540
• UDI-Public: H965457540
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/17/2024

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: 06/19/2023
• Device Model Number: 45754
• Device Catalogue Number: 45754
• Device Lot Number: 5787808
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2023
• Supplement Date Received by Manufacturer: 02/20/2024; 07/10/2024
• Initial Report FDA Received Date: 12/04/2023
• Supplement Report FDA Received Date: 02/27/2024; 07/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown