MAUDE Adverse Event Report: ANGIODYNAMICS ANGIDYNAMICS / MINI STICK MAX; VESSEL DILATOR

Catalog Number	H965457591
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/26/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As the guidewire from the reported event is purchased by (b)(5), the supplier, (b)(4), has been notified of the event, provided with the part number / lot number and sent a supplier corrective action report to perform a review of the device history records.The user medwatch form provided by the fda did not include the name of the reporting hospital, or any contact information, therefore is not possible for (b)(4) to attempt to follow-up on sample availability.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not returned to manufacturer.
Event or Problem Description
As reported on user medwatch mw5064763 : "during attempted peripheral artery angioplasty of left femoral artery, artery was accessed utilizing the micropuncture technique.It was difficult to place the micropuncture sheath over the guidewire into vessel.The guidewire actually broke with part being retained in the iliac artery.The common femoral artery was re-accessed by gaining entry into the vessel.A 4 french angled glide catheter and a 2mm micro snare kit was used to retrieve the broken wire.There were no complications as a result of this event." the form, as received from the fda, did not have any identifying or contact information regarding the complaint reporter.(b)(4) shipping history for the reported lot number indicates that the lot of product was distributed to more than 20 different hospitals.It is therefore not possible to contact the complaint reporter regarding whether the device sample can be returned for evaluation.
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 january 2017 angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "guidewire broke/migrated." no adverse trend was identified.Without receiving a device sample for evaluation we are unable to determine the root cause of the fractured guidewire.Angiodynamics' guidewire supplier, neometrics was notified of the event via a supplier corrective action request, and asked to perform a device history records review.Their review found no discrepancies in the records for the reported device lot.Directions for use provided with the ministick max kit include the following: "precautions: do not advance or withdraw a guidewire against resistance until the cause of the resistance has been determined.Excessive force against resistance may result in guidewire damage or vessel perforation.Caution: 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).Not returned to manufacturer.

• Brand Name: ANGIDYNAMICS / MINI STICK MAX
• Common Device Name: VESSEL DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6053372
• Report Number: 1317056-2016-00159
• Device Sequence Number: 13912812
• Product Code: DRE
• UDI-Device Identifier: H965457591
• UDI-Public: H965457591
• Combination Product (Y/N): N
• PMA/510(K) Number: K123445
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2017

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: 07/31/2019
• Device Catalogue Number: H965457591
• Device Lot Number: 5061463
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/06/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• Supplement Report FDA Received Date: 04/06/2017
• 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