MAUDE Adverse Event Report: ANGIODYNAMICS ANGIODYNAMICS / BIOFLO / DURAMAX; CATHETER, HEMODIALYSIS, IMPLANTED

Device Problems Air Leak (1008); Crack (1135)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/10/2016

Event Type  malfunction  

Manufacturer Narrative

As no part number or lot number were provided, it was not possible to conduct either a shipping history or device history review.The (b)(6) 2016 angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode, "extension leg failure." there were no adverse trends noted.As no sample was returned, a device evaluation was not possible and the root cause of the reported event is unable to be determined.The directions for use packaged with the catheter provides the following warnings: "in the rare event that a hub or connector separates from any component during insertion or use, take all necessary steps and precautions to prevent blood loss or air embolism and remove catheter.Use of excessive pull force on the catheter may cause the suture wing to detach from the bifurcate.Do not use acetone on any part of the catheter tubing.Exposure to this agent may cause catheter damage.Do not use sharp instruments near the extension tubing or catheter lumen.Do not use scissors to remove dressing.Catheter will be damaged if clamps other than what is provided with this kit are used.Clamping of the tubing repeatedly in the same location may weaken tubing.Avoid clamping near the luers and hub of the catheter.Examine catheter lumen and extensions before and after each treatment for damage." angiodynamics manufacturing process controls include 100% leak testing of all catheters, a guidewire insertion test to verify lumen patency, and visual inspections for damage or defects.(b)(4).Device discarded by hospital.

Event Description

As reported, hemodialysis catheter originally placed on (b)(6) 2015, was removed and replaced during the week of (b)(6) (exact date unknown) due to an air leak at the location where the tubing connects to the white luer lock.The used device was discarded at the hospital.The patient condition was described as "unaffected" by the event.

Manufacturer Narrative

Returned for evaluation was a used catheter which was confirmed to have a small crack in the extension tube adjacent to the arterial hub.Measurements were taken of the i.Ds, and o.Ds of the venous and arterial extension tubes.Both were found to be within specification.There is no indication that the failure is related to either the manufacturing process or associated tooling.As a definitive root cause for this event could not be determined 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).

• Brand Name: ANGIODYNAMICS / BIOFLO / DURAMAX
• Type of Device: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• Manufacturer Contact: law ryan ; 10 glens falls technical park; glens falls, NY 12801 ; 5187424488
• MDR Report Key: 5646330
• MDR Text Key: 45044656
• Report Number: 1317056-2016-00063
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K131260
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2016

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
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2016
• Initial Date FDA Received: 05/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1