MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / MINISTICK; MICRO-INTRODUCER SET

Catalog Number	H965457501
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/25/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number (h965457501) in order to determine the last three lots shipped to the reporting hospital in the six months prior to the procedure date.The device history records for the lots obtained through the shr (packaging lots) as well as the guidewire component lots were reviewed 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 august 2017 angiodynamics venous access complaint report was reviewed for the mini-sticks product family and the failure mode "guidewire broke/migrated." no adverse trend was identified.The reported complaint description is unable to be confirmed, nor can a root cause be identified, as no sample was returned for evaluation.The guidewire accessory is supplied to angiodynamics by the supplier heraeus medical.Heraeus medical has been notified of this event via a supplier corrective action request (scar) for informational purposes only.A possible root cause for the fractured guidewire may be that the end user pulled the wire back through the needle.The dfu packaged with the ministick device states: "the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire." (b)(4).
Event or Problem Description
As reported on end user medwatch # (b)(4): "during a femoral access attempt, a 'micropuncture' wire was introduced and resistance was met.Wire was removed with difficulty.Fluoroscopy was done and revealed possible fracture tip of wire left in body.Physician revealed tip had broken off from wire." the wire was not intravascular, but left in the soft tissue.The physician chose not to retrieve the device.".

• Brand Name: ANGIODYNAMICS / MINISTICK
• Common Device Name: MICRO-INTRODUCER SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6894574
• Report Number: 1317056-2017-00078
• Device Sequence Number: 809438
• Product Code: DRE
• UDI-Device Identifier: H965457501
• UDI-Public: H965457501
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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 Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/26/2017

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: Physician
• Device Catalogue Number: H965457501
• 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: 08/24/2017
• Initial Report FDA Received Date: 09/26/2017
• 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