MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / MINI STICK MAX; VESSEL DILATORY FOR PERCUTANEOUS CATHETERIZATION

Catalog Number	H965457561
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The used guidewire was returned to angiodynamics in two pieces.As this component is purchased by angiodynamics from heraeus medical components, it has been forwarded to them, along with a scar (supplier corrective action request).Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported during access for an angiogrm the guidewire from a ministick max broke off into the right femoral artery.The physician was able to remove it all in its entirety with no harm to the patient.The guidewire has been returned to angiodynamics.
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 june 2019 angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "guidewire fractured/migrated." no adverse trend was identified.As the guidewire from the reported event is a purchased device for angiodynamics, it was returned to the supplier, heraeus medical components for evaluation and completion of a supplier corrective action request (scar).Heraeus' review of their device history records confirmed that all units were properly assembled and inspected and were sent within specification and met quality requirements successfully.The returned sample was evaluated and found to be within specification.As the reported issue has been determined not to be the result of a manufacturing defect, it was likely generated during use/in the field.(b)(4).

• Brand Name: ANGIODYNAMICS / MINI STICK MAX
• Common Device Name: VESSEL DILATORY FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8717611
• Report Number: 1317056-2019-00080
• Device Sequence Number: 19385969
• Product Code: DRE
• UDI-Device Identifier: H965457561
• UDI-Public: H965457561
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

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: Health Professional
• Device Expiration Date: 01/31/2022
• Device Catalogue Number: H965457561
• Device Lot Number: 5440444
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Supplement Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 06/20/2019
• Supplement Report FDA Received Date: 08/14/2019
• 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
• Patient Age: 63 YR