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

Catalog Number	H965457110
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/28/2018
Type of Reportable Event	Serious Injury
Additional 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 or Problem 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.
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 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
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 8208403
• Report Number: 1317056-2019-00001
• Device Sequence Number: 18898408
• Product Code: LJS
• UDI-Device Identifier: H965457110
• UDI-Public: H965457110
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2018
• Supplement Date Received by Manufacturer: 12/08/2018
• Initial Report FDA Received Date: 01/02/2019
• Supplement Report FDA Received Date: 04/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention