MAUDE Adverse Event Report: ANGIODYNAMICS, INC MINI STICK MAX; MINI STICK MAX COAXIAL MICROINTRODUCER KIT

Catalog Number	45751
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported device has not been returned to the manufacturer for evaluation.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).
Event or Problem Description
A vascular or technician reported an issue with a mini stick max 4f x 10 cm stiff.018 ss/ss echo 2.75" pg.During a tavr procedure, a piece of the micropuncture sheath/introducer broke off into the patient's femoral vein.It was reported that the fragment was deemed " too high risk to remove;" therefore, the decision to leave in situ was made.At this time, the device remains with the hospital's risk management team.The patient has not experienced any adverse effects or harm as a result of this incident.
Additional Manufacturer Narrative
The customer's reported complaint description of the sheath tubing detached inside patient cannot be confirmed.No sheath complaint sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Device history record (dhr) review of the packaging/introducer lots revealed no quality related issues or manufacturing deficiencies at the time of manufacture.Potential root cause for this type of failure mode is tubing being nicked by sharp object (e.G.Scalpel) and then pulled to failure resulting in distal end of tubing migrating into the vasculature.(b)(4) was sent to sheath/dilator supplier/manufacturer, medron medical, for awareness and dhr review of supplier lot numbers.Medron confirmed no internal non-conformance reports were found regarding batch in question.This event cannot be confirmed to be a manufacturing issue.Labeling review: direction for use (dfu, 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.Intended use/ indications for use: the coaxial microintroducer kit is used for the percutaneous introduction of a guidewire into the vascular system.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: MINI STICK MAX COAXIAL MICROINTRODUCER KIT
• 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: 18939417
• Report Number: 1317056-2024-00051
• Device Sequence Number: 12505412
• Product Code: DRE
• UDI-Device Identifier: H965457510
• UDI-Public: H965457510
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 04/23/2024

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 Catalogue Number: 45751
• Device Lot Number: 5809104
• 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: 03/01/2024
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/03/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 82 YR
• Patient Sex: Male
• Patient Weight: 171 KG