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

Catalog Number H965457110

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2018

Event Type  Injury  

Manufacturer Narrative

It has been indicated that the device from the reported event will be returned for evaluation, however it has not yet been returned to the manufacturer.Upon receipt of the device, and completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).

Event Description

As reported, end user hospital reported lack of blood flow/clotting occurring with picc.Device was removed and replaced.Similar issues have occurred with multiple units of this catheter; however, discrete event information was not provided by the hospital.

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 power injectable picc w/ pasv product family and the failure mode "catheter occluded {treatment}." no adverse trend was indicated.Returned for evaluation were thirty-three unused/unopened samples of reported lot {5386743}.No used sample was returned.Visual/microscopic exam: sample inspection of n=13 units from the 33 returned devices were tested to evaluate the reported catheter occluded performance issues.Visual inspection of the samples did not identify any manufacturing non-conformances.The valves {13 pcs} were visualized microscopically.The valves discs were confirmed to be slit and centered.No molding/manufacturing related non-conformances were noted to the returned samples.There were no kinks, compressions or other damage noted to the returned catheters.Functional check: 13 samples tested: a 10ml syringe was used to infuse water through the valve and through the catheter.The tip of the catheter was clamped and each lumen was pressurized one at a time with water using a 10 ml syringe.There was no external or inter-lumen leak between lumens noted.A guidewire (0.018") was inserted through the lumens of the returned sample without difficulty, confirming patency.The end user hospital's reported complaint description cannot be confirmed.Thirteen (13) of the returned unused devices were tested and all passed performance testing - devices met specification and no manufacturing non-conformances were observed, thus the complaint does not appear to be a manufacturing related issue.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." (pr (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: 8208403
• MDR Text Key: 131789422
• Report Number: 1317056-2019-00001
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: H965457110
• UDI-Public: H965457110
• 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: 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2020
• Device Catalogue Number: H965457110
• Device Lot Number: 5386743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2019
• Date Manufacturer Received: 12/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention