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

Catalog Number H965457501

Device Problem Material Fragmentation (1261)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 07/25/2017

Event Type  Injury  

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pulled the wire back through the needle.The dfu packaged with the ministick device states: "the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire."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 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
• Type of Device: MICRO-INTRODUCER SET
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 6894574
• MDR Text Key: 87383486
• Report Number: 1317056-2017-00078
• Device Sequence Number: 1
• Product Code: DRE
• UDI-Device Identifier: H965457501
• UDI-Public: H965457501
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132713
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 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
• Device Operator: Physician
• Device Catalogue Number: H965457501
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2017
• Initial Date FDA Received: 09/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 94 YR