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

Catalog Number	H965457310
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation into this event is on-going, as angiodynamics is attempting to obtain the sample for evaluation.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, indwelling xcela picc which had been in place for 2 days, was removed and replaced due to a detached hub.No patient 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 february 2019 angiodynamics complaint report was reviewed for the xcela pasv picc product family and the failure mode "hub detached/separated/fractured." no adverse trend was indicated.In addition, this is the only reported complaint for this failure mode in the past 15 months for the xcela pasv picc product family.The returned device was inspected and the female valved housing was seen to be separated from the male valved housing.Epoxy / adhesive is present on both parts, on all 360 degrees of the bond joint.A dimensional check showed that the separated components fit together as expected.The root cause for the separation is unknown.There were no manufacturing related defects noted in the returned sample.It is possible that it was over-torqued by the end user when the needleless connector was attached.The complaint does not appear to be a manufacturing related issue.This is the only reported complaint for this failure mode in the past 15 months for the xcela pasv picc product family, as such, this is deemed to be an isolated incident.(pr21367).

• Brand Name: ANGIODYNAMICS / XCELA
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8288458
• Report Number: 1317056-2019-00016
• Device Sequence Number: 11367329
• Product Code: LJS
• UDI-Device Identifier: H965457310
• UDI-Public: H965457310
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/29/2019

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: 11/30/2020
• Device Catalogue Number: H965457310
• Device Lot Number: 5404846
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/05/2019
• Supplement Date Received by Manufacturer: 01/05/2019
• Initial Report FDA Received Date: 01/30/2019
• Supplement Report FDA Received Date: 03/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1