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

Catalog Number	H965103038031
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the used device was discarded at the hospital and will not be returned to angiodynamics, the investigation into this event is ongoing.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).Device discarded at hospital.
Event or Problem Description
Bioflo dialysis catheter placed on (b)(6) 2015 via the internal jugular vein.The catheter developed a hole in the extension leg and was removed on (b)(6) 2017.The event occurred in (b)(6).The used catheter was discarded at 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 bioflo dialysis product family and the failure mode, "extension leg failure." no adverse trends were indicated.No sample was returned for evaluation, thus a definitive root cause for the reported event could not be determined.A capa has been initiated to provide further investigation into this and similar events, and to 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).Not received by manufacturer.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6368906
• Report Number: 1317056-2017-00018
• Device Sequence Number: 18943207
• 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: 2015
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2017

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: 01/31/2016
• Device Catalogue Number: H965103038031
• Device Lot Number: 4753225
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/01/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/01/2017
• Supplement Report FDA Received Date: 06/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1