MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO / ANGIODYNAMICS; DIALYSIS CATHETER

Catalog Number	H965103038031
Medical Device Problem Codes	Air Leak (1008); Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the used catheter has been returned to angiodynamics, the device evaluation has not yet been conducted.Upon completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported dialysis catheter had been placed in the patient's right ij on (b)(6) 2016.There were no complications during insertion and the patient, on home hemodialysis, had not had any issues intil the night of (b)(6) 2016, when her circuit filled with air.A hole was confirmed when the patient came in for assessment and the line was replaced.The patient condition was reported to be "unaffected" by the event.The used device is expected to be returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
The angiodynamics (b)(6) 2016 complaint report was reviewed for the bioflo dialysis product family and the failure mode, " extension leg detached/separated/fractured." no adverse trend was indicated.Returned was a used catheter which was confirmed to have a hole in the venous extension tube just below the junction with the female luer.There was no visible indication that the failure is related to either the manufacturing process or the associated tooling.As a definitive root cause for this event could not be determined, a capa has been initiated to provide further investigation and determine if corrective action is required.Manufacturing process controls for the dialysis catheter include visual inspection for damage or defects.100% leak testing, and guidewire insertion testing to verify lumen patency.(b)(4).

• Brand Name: BIOFLO / ANGIODYNAMICS
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6187086
• Report Number: 1317056-2016-00186
• Device Sequence Number: 16351372
• Product Code: MSD
• UDI-Device Identifier: H965103038031
• UDI-Public: H965103038031
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K131260
• 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,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/24/2016

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: 11/30/2017
• Device Catalogue Number: H965103038031
• Device Lot Number: 4888102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/24/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/19/2016
• Supplement Report FDA Received Date: 01/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1