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

Catalog Number	45752
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2021
Type of Reportable Event	Malfunction
Event or Problem Description
An end user reported an issue with a mini stick max 4f x 10cm.During treatment for a patient's dvt in the popliteal vein, the introducer would not advance over the wire; therefore, the entire device and wire were removed from the patient.It was then noted that the outer dilator was fractured.It had split transversely in half, but remained on the wire, so no fragments were retained inside the patient.The procedure was completed with a new of the same device.There was no apparent injury to the patient.
Additional Manufacturer Narrative
The reported defective device has been returned to the manufacturer and 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.(b)(4).
Additional Manufacturer Narrative
Returned for evaluation was one piece of sheath tubing.As received, the customer returned 1 sheath/dilator and 2 pieces of the tubing for evaluation.The tubing ends appeared damaged.The 4f introducer is a purchased accessory from supplier (b)(4).(b)(4) was sent to (b)(4) for sample evaluation/root cause determination and dhr review of supplier lot.As per the (b)(4) report, (b)(4) sheath - the sheath remains intact and the sheath tip was damaged during the procedure.With a new dilator inserted the sheath extrusion id remains open.The tip clearly hit into something that pushed the tip back.Dilator - it appears that during the procedure as the device was pulled out of the patient there was enough of a pinch on the dilator extrusion to stretch it until it broke.On a stiff introducer the dilator extrusion tip will normally be approximately 0.150" past the end of the inner cannula.In this case the dilator stretched to approximately 4.5" past.The extrusion remained attached to the hub.The extrusion did not break until after this long stretch.The fact that it did stretch indicates the hub joint performed properly.During the investigation a guide wire was inserted into the dilator and was able to fully insert thru the full length of the cannula, thus the id was still open.Root cause is likely damage due to handling/use of the device.The customer's reported complaint description of sheath/dilator tubing detached was confirmed as the returned sheath tubing was detached from the hub (hub portion not returned).Root cause is damage due to handling/use of the device.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.Based on sample evaluation it cannot be determined if device was used in a manner inconsistent with labeling.Use of the device is a potential contributing factor as a slice damage was observed on the returned complaint sample.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: 12922968
• Report Number: 1317056-2021-00193
• Device Sequence Number: 5475977
• Product Code: DRE
• UDI-Device Identifier: H965457521
• UDI-Public: H965457521
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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): 12/27/2021

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: 45752
• Device Lot Number: 5692849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2021
• Supplement Date Received by Manufacturer: 12/26/2021
• Initial Report FDA Received Date: 12/03/2021
• Supplement Report FDA Received Date: 12/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/18/2021
• 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 Age: 63 YR
• Patient Sex: Male
• Patient Weight: 87 KG