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	09/16/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The used device from the reported event has not yet been returned to angiodynamics, therefore a 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 by end user hospital in (b)(6), a hole was noted in the extension leg of the dialysis catheter placed on (b)(6) 2016.The catheter was removed and replaced on (b)(6) 2016.The patient condition is reported as "unaffected." the used catheter is expected to be returned to angiodynamics.
Additional Manufacturer Narrative
The angiodynamics october 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.Without receiving a sample for evaluation the complaint was unable to be confirmed.Based on similarly reported events 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).Device not returned to 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: 6053369
• Report Number: 1317056-2016-00157
• Device Sequence Number: 1838257
• 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,distri
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/30/2017
• Device Catalogue Number: H965103038031
• Device Lot Number: 4888102
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/25/2016
• 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
• Outcome Attributed to Adverse Event: Required Intervention