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

Catalog Number	H96560M1636021
Medical Device Problem Code	Unraveled Material (1664)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/02/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device sample from the reported event has been returned to angiodynamics.As the guidewire is a purchased component, it will be forwarded to our supplier for evaluation.Upon completion of the investigation a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported, "guidewire packaged in (picc) kit had a small barb sticking out which would not allow the introducer to pass over the wire." the guidewire was returned to angiodynamics unravelled and in two pieces.When queried, the end user hospital indicated that they "cut the guidewire in half to complete the insertion." 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 recent angiodynamics complaint report was reviewed for the xcela pasv picc product family and the failure mode "guidewire - barb." no adverse trend was identified.The guidewire was returned to angiodynamics in two pieces (per the sales rep, the end user had cut the guidewire in half to complete the insertion).It was then forwarded to lake region mfg., angiodynamics' guidewire supplier, along with a supplier corrective action request (scar).Lake region described the condition of the wire as "kinked, bent, and offset." when examined microscopically, no anomalies were noted to the distal or proximal welds of the guidewire.Based on the condition of the wire and the information provided by the end user, it was not possible to define a definitive root cause for the event.Lake region's review of their device history records indicate that the product met specification prior to shipment.(b)(4).

• 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: 7817936
• Report Number: 1317056-2018-00164
• Device Sequence Number: 1391731
• Product Code: LJS
• UDI-Device Identifier: H96560M1636021
• UDI-Public: H96560M1636021
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K152409
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 12/13/2018

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: 03/31/2019
• Device Catalogue Number: H96560M1636021
• Device Lot Number: 5237535
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 08/27/2018
• Supplement Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1