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

Catalog Number	45785
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the reported defective device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description cannot be confirmed.No sample was returned for evaluation.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A root cause for the reported event could not be determined.A potential root cause for this type of guidewire failure mode is end user pulling the guidewire back against the needle.This is cautioned against in the dfu.The device is a supplied component from (b)(4) components.The supplier was made aware of this event via (b)(4).Without a reported lot number, the supplier was unable to provide a device history records review.The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.The review confirms that the lots met all material, assembly and performance specifications.Labeling review: dfu states: 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force against resistance may result in guidewire damage or vessel perforation.Caution: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire a review of the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).
Event or Problem Description
An end user reported an issue with a micro-puncture kit.During a procedure, the tip of the access wire sheared off during vascular access.The physician tried to snare the part of the wire that came off but was unsuccessful.No further information was provided.It was indicated that the reported device is not available to be returned to the manufacturer for evaluation.There was no report of permanent patient harm or injury.

• 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: 11429666
• Report Number: 1317056-2021-00057
• Device Sequence Number: 14456559
• Product Code: DRE
• UDI-Device Identifier: H965457851
• UDI-Public: H965457851
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/07/2021

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 Catalogue Number: 45785
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 03/07/2021
• 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