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

Catalog Number	45753
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Device Embedded In Tissue or Plaque (3165); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
A cardiovascular invasive specialist reported an issue with a mini stick max 4f x 10cm stiff.018 ni/tu echo2.75" pg.During a procedure, the shaft of the sheath broke off in the femoral, while the physician was attempting to exchange.Another sheath was pulled in order to complete the procedure.The physician had to snare the remaining shaft out of the patient.The patient did not experience any adverse effects, harm, or require medical intervention as a result of this incident.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.
Additional Manufacturer Narrative
It was reported that the disposable 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
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.However, a photograph of the device's reported defect was provided by the end user.The customer's reported complaint description of sheath/dilator tubing detached was confirmed based on pictures supplied by the customer, however, without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Based on tubing detachment location from the picture provided, a potential root cause is slice damage to sheath tubing from sharps with subsequent pull/tensile to failure of the tubing.The 4f introducer is a purchased accessory from supplier medron, llc.(b)(4) and picture were sent to medron for dhr review of supplier lot.As per the (b)(4) report, medron, llc performed a dhr review of the reported lot and found no indication of a manufacturing defect that could have impacted the reported event.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 {dfu} 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).

• Brand Name: MINI STICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587805
• MDR Report Key: 12842739
• Report Number: 1317056-2021-00186
• Device Sequence Number: 4232303
• Product Code: DRE
• UDI-Device Identifier: H965457531
• UDI-Public: H965457531
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/25/2022

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: 08/31/2024
• Device Catalogue Number: 45753
• Device Lot Number: 5693767
• 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: 10/29/2021
• Supplement Date Received by Manufacturer: 01/22/2022
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 01/25/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/23/2024
• 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