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

Catalog Number	H965457591
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the device from the reported event will be returned for evaluation, it has not yet arrived at (b)(4).Upon receipt of the returned sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, mini stick max dilator hub detached while the sheath was in the patient's vein.The device was able to be removed in it's entirety and the patient condition was "unaffected." a new sheath was used and the procedure continued.It has been indicated that the damaged sheath will be returned for evaluation.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number h965457531 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 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 recent angiodynamics complaint report was reviewed for the mini sticks product family and the failure mode "hub detached." no adverse trend was identified.As the sheath/dilator assembly is a purchased component for angiodynamics, the returned sample was forwarded to the supplier, (b)(4) , along with a supplier corrective action request (scar).(b)(4) reviewed the complaint sample and confirmed that the sheath tubing experienced the typical elongation that occurs prior to a fracture resulting from excessive tensile force placed on the shaft extrusion.This is evident by the elongation shown in the shaft extrusion which indicates that the hub-to-shaft join strength was higher than the tensile strength of the tubing.It was confirmed that the internal retention flange was formed and located correctly and that the location and standard capture depth of the sheath inside the molded hub cavity was correct.The point of fracture occurred at the flange-to-shaft transition.All final quality assurance visual and tensile results were found to be within specification.The most likely root cause is excessive force applied by the end user.((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: 6571961
• Report Number: 1317056-2017-00039
• Device Sequence Number: 18984800
• Product Code: DRE
• UDI-Device Identifier: H965457591
• UDI-Public: H965457591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: H965457591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/03/2017
• Supplement Date Received by Manufacturer: 05/03/2017
• Initial Report FDA Received Date: 05/17/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1