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

Catalog Number	H965251290
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Fluid Discharge (2686)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history review (shr) was performed for the reporting hospital to determine the last 3 lots shipped to the hospital in the 6 months prior to the procedure date.A review of the device history records was performed for the packaging and component lots obtained through the shr for any deviations related to the reported issue of the complaint.The review confirms that the lots met all material, assembly and performance specifications.The angiodyanamics july 2016 complaint report was reviewed for the xcela pasv picc product family and the failure mode, "catheter leaked - removed." no adverse trends were indicated.The device was not returned for evaluation, as it was discarded at the hospital following its removal.Therefore, a failure analysis is not available and we are unable to determine if the device met specification, and the relationship, if any, between the device and the reported event.Angiodynamics' manufacturing process controls for the xcela pasv picc device include a 100% visual inspection for molding defects, a guidewire insertion test to verify lumen patency, and 100% leak testing after guidewire verification.The directions for use provided with the device contains the recommended procedure for flushing and blood sampling.(b)(4).Device discarded at hospital.
Event or Problem Description
As reported, several hours after the picc was placed, leakage was noted at the insertion site following a flush.The picc was removed and replaced.

• 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: 6024387
• Report Number: 1317056-2016-00152
• Device Sequence Number: 544984
• Product Code: LJS
• UDI-Device Identifier: H965251290
• UDI-Public: H965251290
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• 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
• Report Date (Section B): 09/15/2016

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 Catalogue Number: H965251290
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/15/2016
• Initial Report FDA Received Date: 10/12/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1