MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO; HEMODIALYSIS 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	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the used device will be returned to angiodynamics, to date, it has not arrived.Upon evaluation of the returned device and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by hospital in (b)(6): bioflo dialysis catheter placed in patient's right internal jugular on (b)(6) 2016.It developed a hole inder the luer/hub of the catheter and was removed on (b)(6) 2017.No patient complications were reported.The used catheter will be returned to angiodynamics for evaluation.
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 (b)(6) 2017 angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode, "extension leg failure." no adverse trends were indicated.The returned catheter was visually examined and a hole was noted in the arterial extension tube adjacent to the flat section of the hub, i.E., 90 degrees from the molded parting line.There is no visible indication that the failure is related to either the manufacturing process or associated tooling.A definitive root cause was unable to be determined based on the sample examination.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).

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6998717
• Report Number: 1317056-2017-00092
• Device Sequence Number: 1354094
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2017

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: Other Health Care 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: 11/02/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 10/11/2017
• Initial Report FDA Received Date: 11/03/2017
• Supplement Report FDA Received Date: 11/16/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1