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

Catalog Number	H965457591
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	05/18/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Although the device from the reported event will not be returned, angiodynamics' supplier of the ministick guidewire, (b)(4), will be notified of the event and asked to evaluate their manufacturing records.An update on the patient condition is also being requested from the hospital.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, during a left heart catheterization the physician pulled the wire back thru the needle and severed the tip of the wire inside the patient.The length of the wire still inside the patient was approx.1.5 cm.The wire was discarded.A vascular surgeon was consulted and the physician is considering leaving the wire inside the patient.The patient's condition is listed as "ok.".
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 recent angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "guidewire fractured/migrated." no adverse trend was indicated.The reported complaint cannot be confirmed for wire fractured/migrated as the end user only returned 2cm of the guidewire for evaluation.Per the event description, the guidewire was pulled back against the needle which is cautioned against in the directions for use.This end user error is the likely root cause of this event.The dfu contains the following statements: the guidewire should not be withdrawn through the introducer needle.If the guidewire must be withdrawn while still inside the needle, simultaneously remove both the needle and the wire as a unit to prevent the needle from damaging the guidewire." although angiodynamics purchases this guidewire from heraeus medical components, notification of the supplier is not required as the cause of the guidewire fracture was identified in the event description.((b)(4)).

• Brand Name: ANGIODYNAMICS / MINI STICK MAX
• Common Device Name: SHEATH/DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7596563
• Report Number: 1317056-2018-00108
• Device Sequence Number: 1422925
• Product Code: DRE
• UDI-Device Identifier: H965457591
• UDI-Public: H965457591
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 09/12/2018

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: Physician
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: H965457591
• Device Lot Number: 5321036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/18/2018
• Supplement Date Received by Manufacturer: 05/18/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 09/13/2018
• 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