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

Catalog Number	H965457521
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/11/2018
Type of Reportable Event	Serious Injury
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) 2018 angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "guidewire broke/migrated." no adverse trend was identified.Angiodynamics was unable to obtain any additional information regarding the event or the use of the device as no end user hospital name or contact information was included on the voluntary medwatch form.The form did state that no sample would be returned to angiodynamics.The reported complaint description cannot be confirmed, nor can a potential root cause be determined without a sample evaluation.Possible root cause may be the guidewire was pulled back against the needle which is cautioned against in the directions for use (dfu).The dfu packaged with the ministick lists "guidewire shearing, fracture or embolization" as a potential adverse event.The dfu additionally contains 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force against resistance may result in guidewire damage or vessel perforation.Caution: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire." the guidewire accessory is supplied to angiodynamics by the supplier (b)(6).(b)(6) has been notified of this event via (b)(4) for informational purposes only.(b)(4).
Event or Problem Description
Per voluntary medwatch mw5077673, "micropuncture wire fractured while inside of patient, requiring incision to remove." the medwatch indicated that the sample was retained by the reporting hospital, however no information as to the name of nor contact information for the hospital was included.

• 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: 7677143
• Report Number: 1317056-2018-00137
• Device Sequence Number: 19044678
• Product Code: DRE
• UDI-Device Identifier: H965457521
• UDI-Public: H965457521
• Combination Product (Y/N): N
• PMA/510(K) Number: K132713
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/11/2018

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: Health Professional
• Device Expiration Date: 02/28/2021
• Device Catalogue Number: H965457521
• Device Lot Number: 5304975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2018
• Initial Report FDA Received Date: 07/11/2018
• 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