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

Catalog Number H965457310

Device Problem Infusion or Flow Problem (2964)

Patient Problems Pain (1994); Thrombosis (2100)

Event Date 10/06/2018

Event Type  Injury  

Manufacturer Narrative

It has been reported that a sample will be returned to angiodynamics for evaluation, but to date, nothing has been received.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).

Event Description

As reported valved xcela picc placed on (b)(6)."pain with flushing the next day and unable to draw blood, line not being used until duplex (ultrasound), dvt found." line removed on (b)(6).

Manufacturer Narrative

Corrections: section b1 - changed to adverse event.Section b2 - checked other serious.Section h1 - changed to serious injury.Section h6 - patient code added 2100 thrombosis.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 december 2018 angiodynamics complaint report was reviewed for the xcela pasv picc product family and the failure mode "catheter occluded {treatment}." no adverse trend was identified.The used device from the reported event was not returned to angiodynamics for evaluation, therefore the failure was unable to be confirmed and the root cause unable to be determined.Previously, however, 13 unused devices from the same product lot had been returned by the end user hospital and had been tested : the valves and catheter tubing were found to be undamaged, with the valves slit and centered.When infused with pressurized water, no leakage occurred.The lumens were subjected to a guidewire insertion test and found to be unobstructed.The devices functioned as intented.The directions for use (dfu) provided with the xcela pasv picc contains the following directions and precautions: "flush the catheter after every use, or at least every seven days when not in use, to maintain patency.Use a 10 ml syringe or larger.- flush the catheter with a minimum of 10 ml of sterile normal saline, using a "pulse" or "stop/start" technique.Precaution: if resistance is met when flushing, it is recommended that no further attempts be made.Further flushing may result in catheter rupture.Refer to institutional protocol for clearing occluded catheters.Precaution: never forcibly flush an obstructed lumen.If either lumen develops a thrombus, first attempt to aspirate the clot with a syringe.If aspiration fails, consult institutional protocol for management of thrombosis." (b)(4).

• Brand Name: ANGIODYNAMICS / XCELA
• Type of Device: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8034260
• MDR Text Key: 127076622
• Report Number: 1317056-2018-00189
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H965457310
• UDI-Public: H965457310
• Combination Product (y/n): N
• PMA/PMN Number: K091261
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2019
• Device Catalogue Number: H965457310
• Device Lot Number: 5380749
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/09/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other