MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / MINISTICK MAX; VESSEL DILATOR

Catalog Number	H965457591
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated 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.The angiodynamics (b)(6) 2018 complaint report was reviewed for the mini sticks product family and the failure mode "guidewire broke/migrated." no adverse trend was indicated.The hospital's reported complaint description cannot be confirmed; no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.Possible root cause may be that the guidewire was pulled back against the needle which is cautioned against in the directions for use (dfu).The dfu contains the following statements: "the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire." additionally there is the precaution, " 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." (b)(4).
Event or Problem Description
As reported, regarding ministick, "during attempts at femoral access, the physician attempted to remove the wire and needle to re-attempt.While pulling back, resistance was met and as he began pulling slightly more, the wire tip broke off inside the subcutaneous tissue." no patient complications were reported.The used device was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / MINISTICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7655385
• Report Number: 1317056-2018-00125
• Device Sequence Number: 1651991
• Product Code: DRE
• UDI-Device Identifier: H965457591
• UDI-Public: H965457591
• 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
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/02/2018

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?: No
• Operator of Device: Physician
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: H965457591
• Device Lot Number: 5321036
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 07/02/2018
• 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: Required Intervention