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

Model Number	M001459841
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/27/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sheath from the reported event has been returned to angiodynamics.As this is a purchased component, it was then forwarded to our supplier, (b)(4).For evaluation and completion of a supplier corrective action request (scar).Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, during a catheter placement procedure, both tabs on the peel-away introducer snapped off, thus it could not be separated.There was no patient injury associated with this event.The used sheath has been returned for evaluation.
Additional Manufacturer Narrative
A review of the device history records (dhr) 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 complaint report was reviewed for the mini sticks product family and the failure mode, " wings detached." no adverse trend was indicated.The used sheath was returned to angiodynamics and the reported failure was confirmed.As the sheath is a purchased component for angiodynamics, the returned sample, as well as a supplier corrective action request (scar) was forwarded to (b)(4), the manufacturer.The scar response from (b)(4) stated that the root cause of the device failure was due to improper tube placement during molding.(b)(4) has initiated a capa to further investigate handle detachment issues.Angio dynamics incoming inspection of the sheaths includes a visual aql to verify that the sheath tubing is undamaged, is free of defects, meets dimensional specification, and that it properly breaks at the hub an separates into two complete pieces when the wings are pulled apart.(b)(4).

• Brand Name: ANGIODYNAMICS / VAXCEL MINI STICK
• Common Device Name: SHEATH / DILATOR
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6112421
• Report Number: 1317056-2016-00167
• Device Sequence Number: 13543874
• Product Code: LDF
• UDI-Device Identifier: M001459841
• UDI-Public: M001459841
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K971165
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/27/2017

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 Expiration Date: 08/31/2018
• Device Model Number: M001459841
• Device Lot Number: 5080061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/27/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/18/2016
• Supplement Report FDA Received Date: 03/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1