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

Catalog Number	M001456760
Medical Device Problem Code	Crack (1135)
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
Although the device from the reported event is expected to be returned to angiodynamics, it has not yet arrived.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).Device not yet returned to manufacturer.
Event or Problem Description
As reported by angiodynamics' distributor in the (b)(6): the hub of the picc fell off onto the floor while the patient was at home.Picc was removed and replaced.Saline was being used as catheter lock solution between treatments.No patient injury was reported.The used device is expected to be returned to angiodynamics.
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 angiodynamics march 2016 complaint report was reviewed for the xcela picc product family and the failure mode "hub extension tubing cracked/detached." no adverse trends were indicated.Visual examination of the returned device confirmed the molded luer was completely detached from the extension tube.The evaluation of the returned sample did not reveal any molding/manufacturing related non-conformance, i.E.No sink marks, short shots or heat damage.The hub-to-extension tubing junction was measured and found to meet id specification.Additionally, the tubing was cross-sectioned, measured, and found to meet id and od specifications and not show any wall thickness abnormalities.A potential root cause for the fracture could be erosion of the extension tubing at the hub joint due to prolonged exposure to alcohol and/or a similar cleansing agent.Extended chemical exposure may weaken the tubing-to-hub joint and make it more susceptible to fracture during handling of the hub/extension tubing during picc access.A contributing factor may also be excessive twisting of the hub-to-extension tubing joint during site cleansing.Manufacturing process controls for the picc device includes a 100% visual inspection of the tubing/luer interface, tensile testing of the molded luer-to-tube connection, a guidewire insertion test for lumen patency, and 100% leak testing.The directions for use packaged with the device contains information for the end user to reference in order to maintain the integrity of the catheter.The information that is provided includes, but is not limited to the following: "- do not use the catheter with chemicals that are incompatible with any of its accessories, as catheter damage may occur.- acetone and polyethylene glycol-containing ointments should not be used with polyurethane catheters, as these may cause failure of the device.- incompatible drug delivery within the same lumen may cause precipitation.Flush catheter lumen following each infusion.Catheter securement: - prepare securement site with alcohol and remove betadine, if present.- apply skin prep solution for enhanced adherence and skin protection.Allow skin prep solution to completely dry (10-15 seconds).Care of insertion site and dressing: warning: prior to dressing catheter and access site, inspect both to assure they are completely dry of isopropyl alcohol-based cleansing agents.All efforts are to be made to keep insertion site and dressing clean, dry and intact." (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: 5587101
• Report Number: 1317056-2016-00055
• Device Sequence Number: 942368
• Product Code: LJS
• UDI-Device Identifier: M001456760
• UDI-Public: M001456760
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070002
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2016

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: 06/30/2017
• Device Catalogue Number: M001456760
• Device Lot Number: 4903447
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/22/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/19/2016
• Supplement Report FDA Received Date: 05/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1