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

Catalog Number	H965457541
Medical Device Problem Codes	Material Fragmentation (1261); Uncoiled (1659)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the guidewire which is the subject of this report is a purchased component for angiodynamics, the guidewire supplier, heraeus medical, is being made aware of the event via a scar (supplier corrective action request).Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
Per user medwatch mw5076679: " patient was having cardiac catheterization when the right femoral artery access was attempted with micro puncture kit.Micro puncture wire unraveled and became stuck in the patient's groin.Dr.Attempted to pull wire out under x-ray and wire kept unraveling and broke off.Dr.Was able to retrieve wire and hold with hemostat.Surgeon attempted to remove wire and patient was taken to the operating room for controlled removal of the remaining wire.The wire was successfully removed.".
Additional Manufacturer Narrative
A review of the device history records (dhr) 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 recent angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "guidewire broke/migrated." no adverse trend was identified.The guidewire is purchased by angiodynamics from (b)(4) and they were notified of the event via supplier corrective action request (scar), and ask for a dhr review.Their review stated that "there was no observation made during records review that identify any contributing factors to the failure reported.All inspections results were recorded within specification limits.The product specifications were met with no non-conformities reported for manufacturing and inspection." the cause of the reported event is unable to be determined from the information provided.The directions for use packaged with the mini stick provides guidance on guidewire placement and removal techniques.((b)(4)).

• Brand Name: ANGIODYNAMICS / MINI STICK MAX
• Common Device Name: DILATOR, VESSEL FOR PERCUTANEOUS CATHETERIZATION
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7556239
• Report Number: 1317056-2018-00095
• Device Sequence Number: 18890271
• Product Code: DRE
• UDI-Device Identifier: H965457541
• UDI-Public: H965457541
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/07/2018

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: 01/31/2021
• Device Catalogue Number: H965457541
• Device Lot Number: 5296430
• 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: 05/08/2018
• Supplement Date Received by Manufacturer: 05/08/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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