MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO / DURAMAX; HEMODIALYSIS CATHETER

Catalog Number	H965103029041
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/13/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As no lot number was reported, a ship history report (shr) was generated for item number h965103029041 in order to ascertain the last three lots shipped to the reporting customer in the six months prior to the event date.The device history records for the lots obtained through the shr were reviewed 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 (b)(6) 2016 angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "occluded." no adverse trend was identified.As no sample was returned for evaluation, the reported complaint is unable to be confirmed and the root cause unable to be identified.This is the only reported complaint for this failure mode in the past 15 months for the bioflo dialysis product family.Angiodynamics manufacturing process controls for this device include a visual inspection based on aql, which includes but is not limited to, visualizing for scratches, cuts, and kinks as well as 100% leak testing of all catheters and guidewire insertion tests to verify lumen patency.The directions for use packaged with the device provides guidance and warnings intended to prolong the life of the catheter, including the statement, "· examine catheter lumen and extensions before and after each treatment for damage.Note: endexo technology is intended to reduce catheter-related thrombus, and is not intended to treat or eliminate existing thrombus." (b)(4).Device discarded at hospital.
Event or Problem Description
As reported, bioflo dialysis catheter became occluded and was removed and replaced in a patient.Patient condition was reported as, "unaffected." the used catheter was discarded at the hospital.

• Brand Name: ANGIODYNAMICS / BIOFLO / DURAMAX
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 5644817
• Report Number: 1317056-2016-00065
• Device Sequence Number: 199809
• Product Code: MSD
• UDI-Device Identifier: H965103029041
• UDI-Public: H965103029041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/13/2016

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: No Information
• Device Catalogue Number: H965103029041
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2016
• Initial Report FDA Received Date: 05/10/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 80 YR