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

Catalog Number	H965251260
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device has been returned to angiodynamics, however the device evaluation is on-going.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
Picc placed on (b)(6) in patient's rt cephalic.It was noticed that the blood was backing up into the orange lumen of the picc.The picc was removed and replaced with a cuffed cvc.
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 may 2016 angiodynamics complaint report was reviewed for the xcela pasv picc product family and the failure mode "catheter kinking {treatment}." no adverse trend was identified.A visual inspection of the catheter tubing showed no kinks, compression, or other damage.The valves were visualized microscopically.The valves discs were confirmed to be slit and centered.There were no molding/manufacturing related non-conformances noted to the returned sample.A 10ml syringe was used to infuse and aspirate water through the catheter.Infusion and aspiration were performed without difficulty.The catheter was primed and then clamped at the distal end.Using the 10 ml syringe, an attempt to inject fluid was unsuccessful, confirming no leakage in the catheter.The infusion and aspiration pressures were measured on each pasv valve using a water column and a ruler; in each case the pressures met specification.Dimensional checks were taken of the catheter tubing od, lumen height, lumen width, wall thickness and septum thickness.All dimensions meet specification.No manufacturing non-conformances were observed during sample evaluation and the catheter tubing met dimensional specifications.Potential contributing factors for this complaint may be catheter positioning techniques used during the placement procedure or patient anatomy.The directions for use contains the following precautionary statements: "- if catheter and accessories show any sign of damage (crimped, crushed, cut, etc.), do not use.Do not fully insert catheter up to suture wing.Avoid sharp or acute angles during insertion which may compromise catheter functionality.Following institutional policy, secure catheter externally to prevent catheter movement, migration, damage, kinking or occlusion." ((b)(4)).

• Brand Name: ANGIODYNAMICS / XCELA PICC WITH PASV
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5751887
• Report Number: 1317056-2016-00098
• Device Sequence Number: 13458657
• Product Code: LJS
• UDI-Device Identifier: H965251260
• UDI-Public: H965251260
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K091261
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/31/2016

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: 04/30/2018
• Device Catalogue Number: H965251260
• Device Lot Number: 5021871
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/23/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/27/2016
• Supplement Report FDA Received Date: 07/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR