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	06/19/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although it has been indicated that the used catheter will be returned to angiodynamics for evaluation, it has not yet arrived.Upon receipt of the sample and completion of the investigation, a supplemental medwatch will be submitted.(b)(4).
Event or Problem Description
As reported by a (b)(6) hospital, a dialysis catheter was placed in the right subclavian on (b)(6) 2015.Because of a hole in the catheter extension tubing the device was removed and replaced on (b)(6) 2017.There were no patient injuries or complications.
Additional Manufacturer Narrative
As no lot number was provided, a ship history report (shr) was generated to determine the last 3 lots shipped to the reporting hospital in the 6 months prior to the reporting date.The lots identified by the shr were reviewed and the review confirms that the lots met all material, assembly and performance specifications.The july 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: DIALYSIS CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 6700706
• Report Number: 1317056-2017-00052
• Device Sequence Number: 2013870
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2017

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 Catalogue Number: H965103038031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 07/11/2017
• Supplement Report FDA Received Date: 09/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1