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

Catalog Number	H965103038041
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Burning Sensation (2146)
Date of Event	09/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device from the reported event has been returned to angiodynamics, however the evaluation has not yet been conducted.Upon completion of the investigation, a supplemental medwatch will be submitted.((b)(4)).
Event or Problem Description
A tunneled dialysis catheter was removed and replaced because the patient complained of "burning pain" at the tunnel site.No further complications were reported.The used catheter was returned to angiodynamics for evaluation.
Additional Manufacturer Narrative
In lieu of a reported lot number, a ship history report (shr) was generated for item number ((b)(4)) in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The device history records (dhr) for the lots obtained through the ship history report (packaging lots) were reviewed 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 january 2016 angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "catheter leaked - removed." no adverse trend was identified.It was noted during the visual inspection of the returned device that the catheter was cut off distal to the cuff.No other damage was noted to the returned bioflo dialysis catheter.Functional check: the end of the catheter was clamped and each lumen was pressured with air at 76 psi one at a time.There were no leaks detected.Dimensional check: per catheter tubing drawing the tubing od, lumen width, wall thickness and septum thickness dimensions were verified using calipers and found to meet specification.The customer's reported complaint of burning pain at the tunnel site cannot be confirmed.The sample was evaluated and was found visually, dimensional and functionally acceptable.The customer's complaint does not appear to be a manufacturing related issue.The directions for use packaged with the catheter contain guidance for placement.Angiodynamics process controls include a visual inspection based on aql as well as a 100% sprint leak test and guidewire insertion test 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: 6010773
• Report Number: 1317056-2016-00153
• Device Sequence Number: 18842110
• Product Code: MSD
• UDI-Device Identifier: H965103038041
• UDI-Public: H965103038041
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Radiologic Technologist
• Type of Report: Initial,Followup
• Report Date (Section B): 03/22/2017

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: Health Professional
• Device Catalogue Number: H965103038041
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 09/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/07/2016
• Supplement Report FDA Received Date: 03/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1