MAUDE Adverse Event Report: ANGIODYNAMICS, INC MINI STICK MAX; DILATOR, VESSEL

Catalog Number	45748
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
An end user reported and issue with a mini stick max 4f x 10 cm std.018 ss/ss echo 2.75" pg.During a procedure, the guidewire sheered when removing and part of the guidewire remained in the access vein of the patient.The patient required surgery to remove the fragment.Despite multiple requests, no further details have been obtained.
Additional Manufacturer Narrative
The reported device has been returned to the manufacturer.An investigation into the root cause for event is currently in progress.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 fractured and detached was confirmed based on visual inspection of the returned guidewire complaint sample; it was received unraveled with tip detached and not returned.The guidewire accessory device is supplied to angiodynamics by the supplier/manufacturer heraeus medical.Scar004944 and guidewire sample were sent to heraeus for sample evaluation/root cause determination and dhr review of the supplier lots.Per (b)(4) response from heraeus medical, based on the event description, the pictures and samples provided by the customer, the evaluation method used for the investigation was review of the device history record, and sample evaluation.No deviations or nonconformances related to the event description were identified in the record review.Evaluation of the sample indicated no non-conformities to the specifications.There is no evidence to confirm the issue is due to the manufacturing process.Therefore, this event is considered a non-manufacturer-related issue.Visual and dimensional inspection of the guidewire indicated it was built to device specifications.Likely root cause of the guidewire detachment is excessive torque/tensile force applied to core wire during device use (handling damage) and/or pulling the guidewire back against the needle which is cautioned against in the device dfu.Labeling review: the instructions for use which is supplied to the end user with this catalog number (16600601-01): 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).

• Brand Name: MINI STICK MAX
• Common Device Name: DILATOR, VESSEL
• Manufacturer (Section D): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS, INC; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 19258760
• Report Number: 1317056-2024-00072
• Device Sequence Number: 2685450
• Product Code: DRE
• UDI-Device Identifier: H965457480
• UDI-Public: H965457480
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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
• Report Date (Section B): 07/23/2024

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2026
• Device Catalogue Number: 45748
• Device Lot Number: 5805360
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/18/2024
• Supplement Date Received by Manufacturer: 07/10/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization; Life Threatening
• Patient Age: 58 YR
• Patient Sex: Male