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

Catalog Number	H965457531
Medical Device Problem Codes	Crack (1135); Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/04/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although no sample will be returned for evaluation, the investigation into this event is on-going.The guidewire is a purchased device for angiodynamics and the manufacturer, neomedtrics will be involved in the investigation via a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device will not be returned.
Event or Problem Description
During access to the popliteal vein, the guidewire in the micro-access kit sheared apart.The physician was successfully able to retrieve a small piece of wire from the patient's leg.The device from the reported event is being retained by the hospital and will not be 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 (b)(6) 2017 angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode, "guidewire broke/migrated." no adverse trend was identified.A supplier corrective action request, (scar) was forwarded to angiodynamics guidewire supplier, neometrics, however no device sample was returned from the complaint reporter.A photo was provided, but the image resolution was of poor quality.Neometrics stated that the image of the guidewire was "consistent with an elongated coil when tensile force was applied to the wire, " however, without a sample they were unable to determine a definitive cause for the broken wire.They reviewed their manufacturing records and no non-conformances were observed which would have contributed to this event.The guidewire lots passed all in-process and final inspection which included tensile and o.D.Inspections.(b)(4).Device not returned to manufacturer.

• 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: 5922530
• Report Number: 1317056-2016-00139
• Device Sequence Number: 18928770
• Product Code: DRE
• UDI-Device Identifier: H965457531
• UDI-Public: H965457531
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2017

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: 05/31/2019
• Device Catalogue Number: H965457531
• Device Lot Number: 5038665
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/01/2016
• Supplement Report FDA Received Date: 04/04/2017
• 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