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

Catalog Number	H965103028080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/13/2017
Type of Reportable Event	Malfunction
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 (b)(4) complaint report was reviewed for the bioflo dialysis product family and the failure mode, "extension leg failure." no adverse trend was indicated.As the catheter from the reported event was discarded at the hospital no device evaluation was possible and a definitive root cause for this event could not be determined.A capa has been initiated, however, to provide further investigation into this and similar events, and to determine if corrective action is required.Manufacturing process controls for the dialysis catheters include visual inspection for damage or defects, 100% leak testing, and guidewire insertion testing to verify lumen patency.(b)(4).
Event or Problem Description
Event occurred in (b)(6) - patient had dialysis catheter implanted on (b)(6) 2016.Catheter was removed on (b)(6) 2017 due to leakage at the extension tubing of the catheter.No patient complications other than changing out the catheter.The patient had been connecting themselves for home dialysis five times per week.The dressing was changed every 2 days and the site was cleaned with 70% alcohol.Tego connectors were used for connection.Those were changed once per week after a 30 second scrub and 2 min.Drying time using chlorhexidine with 4% alcohol solution.The catheter from the reported event was discarded by the hospital.

• 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: 6395976
• Report Number: 1317056-2017-00024
• Device Sequence Number: 747300
• Product Code: MSD
• UDI-Device Identifier: H965103028080
• UDI-Public: H965103028080
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/10/2017

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: Lay User/Patient
• Device Expiration Date: 03/31/2018
• Device Catalogue Number: H965103028080
• Device Lot Number: 4948424
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2017
• Initial Report FDA Received Date: 03/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR