MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / XCELA PICC WITH PASV; PERIPHERALLY INSERTED CENTRAL CATHETER

Catalog Number	H965457330
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this event is still in process.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
As reported, after placing a dual lumen picc line, the valve on one of the lumens allowed blood to come back.The picc line was replaced.No patient injury or complications were reported.
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)(4) 2016 angiodynamics complaint report was reviewed for the xcela picc w/pasv product family and the failure mode "leakage - valve / blood back-up." no adverse trend was identified.The end user's reported complaint description cannot be confirmed, nor can a root cause be determined, as no sample was received for evaluation.Angiodynamics manufacturing process controls for this device include verification that each valve disc is properly slit , then centered after it is assembled into the valve housing.Each pasv valve is 100% infusion and aspiration tested to ensure that the valve will open and close at the required pressures.Valves that fail either of these tests are discarded.The xcela pasv picc dfu (directions for use) that is supplied in the applicable kit provides guidelines for the preferred method for blood sampling.(b)(4) device not returned to manufacturer.

• Brand Name: ANGIODYNAMICS / XCELA PICC WITH PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5551882
• Report Number: 1317056-2016-00049
• Device Sequence Number: 384468
• Product Code: LJS
• UDI-Device Identifier: H965457330
• UDI-Public: H965457330
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2016

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: 01/31/2018
• Device Catalogue Number: H965457330
• Device Lot Number: 4986635
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/10/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/06/2016
• Supplement Report FDA Received Date: 07/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1