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

Catalog Number	45749
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The reported defective device has yet to be returned to the manufacturer for a device evaluation.An investigation into the root cause for product problem is currently in progress.The results of the investigation will be sent via a follow up medwatch.(b)(4).
Event or Problem Description
An end user reported an issue with a mini stick max.The guidewire fractured while attempting to remove the wire through the access needle.The patient presented for the procedure with a fistula due to a graft excision.When manipulating the guidewire, the tip fractured off inside of the fistula tissue.The patient is scheduled for a graft revision, so the guidewire piece will be removed at that time.It was indicated the reported device is available for return to the manufacturer for a device evaluation.
Additional Manufacturer Narrative
Returned for evaluation was one piece of guidewire.As received, only a piece of the guidewire was returned for evaluation.The tip was knotted/curled.Angiodynamics' supplier of this device was notified of the event and the sample was forwarded for a device evaluation, root cause determination and correction/corrective action.As per the supplier's response: the observation made during the analysis found that the guidewire was fractured.The distal tip and remaining flat core section were not returned with the guidewire.A microscopic examination of the guidewire proximal joint revealed that the proximal joint was cracked in the middle.The part of the coil right after the joint was stretched and unravelled.Multiple bends were present on the returned guidewire.No other damage was noted on the returned guidewire.A review of the device history records of the specimen device does not present any indication of manufacturing defect or anomaly that could have impacted on the event as reported.The history records indicate this product was final inspection tested at lake region medical and was determined to be acceptable.At this time, it is not possible to assign a definitive root cause for the event as reported.Based on the evidence presented by the sample and the information provided by the supporting documentation, "device forced against resistance", "excessive force used", "device used at sub optimal indications", "excessive force", "inexperienced user", "unanticipated user error" and/or "improper handling" appear to have impacted on the event as reported.A potential root cause for the fracture in the guidewire is pulling the guidewire back against the needle, which is cautioned against in the dfu.Event description states, "the wire fractured while attempting to remove the wire through the access needle".A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.Labeling review: precautions · do not advance or withdraw a guidewire against resistance until the cause of the resistance has been determined.Excessive force against resistance may result in guidewire damage or vessel perforation.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.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
• MDR Report Key: 10731895
• Report Number: 1317056-2020-00174
• Device Sequence Number: 19598158
• Product Code: DRE
• UDI-Device Identifier: H965457491
• UDI-Public: H965457491
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): Y
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/19/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2023
• Device Catalogue Number: 45749
• Device Lot Number: 5589155
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2020
• Supplement Date Received by Manufacturer: 10/14/2020
• Initial Report FDA Received Date: 10/24/2020
• Supplement Report FDA Received Date: 01/19/2021
• 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
• Patient Age: 70 YR