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

Catalog Number	H965103038181
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	05/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As no lot number was reported, a ship history report (shr) was generated for item number (h965103038181) in order to determine the last three lots shipped to the reporting customer in the six months prior to the procedure date.The three lots obtained through the shr were: (5234866, 5242904 and 5277743).The device history records for the lots obtained through the ship history report (packaging lots) were reviewed.In addition, the corresponding lots for the dialysis catheter were reviewed.The review confirms that the lots met all material, assembly and performance specifications.The recent angiodynamics complaint report was reviewed for the bioflo dialysis product family and the failure mode "patient issue - bleeding." no adverse trend was identified.The dialysis catheter was reported to have been discarded at the hospital, therefore a failure analysis is not possible and we are unable to determine if the device met specification, and the relationship , if any, between the device and the cause of the reported event.The directions for use (dfu) packaged with the catheter include the following instructions regarding insertion: "the bioflo duramax dialysis catheter may be inserted percutaneously and is ideally placed in the jugular vein.Although this catheter may be placed in the subclavian vein, the internal jugular is the preferred site.Catheters greater than 40 cm length (tip to cuff) are designed for femoral vein insertion.Use blunt dissection to create the subcutaneous tunnel opening.Attach the catheter to the trocar (a slight twisting motion may be helpful).Slide catheter tunneling sleeve over the catheter making certain that the sleeve covers the distl tip of the catheter.Insert the trocar into the exit site and create a short subcutaneous tunnel.Do not tunnel through muscle.The tunnel should be made with care in order to prevent damage to surrounding vessels.Warning: do not over-expand subcutaneous tissue during tunneling.Over-expansion may delay/prevent cuff in-growth.Lead catheter into the tunnel gently.Do not pull or tug the catheter tubing.If resistance is encountered, further blunt dissection may facilitate insertion.Remove the catheter from the trocar with a slight twisting motion to avoid damage to the catheter.Precaution: do not pull tunneler out at an angle.Keep tunneler straight to prevent damage to catheter tip." (b)(4).
Event or Problem Description
As reported, following the placement of a bioflo dialysis catheter in the ij, the patient "bled for hours post insertion." further description - " it accumulates under the skin and out the tunnel tract." the catheter was removed and replaced, and was disposed of at the hosptial.

• Brand Name: ANGIODYNAMICS / BIOFLO
• Common Device Name: HEMODIALYSIS CATHETER, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls NY 12801
• MDR Report Key: 7564994
• Report Number: 1317056-2018-00099
• Device Sequence Number: 1980354
• Product Code: MSD
• UDI-Device Identifier: H965103038181
• UDI-Public: H965103038181
• 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 Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/04/2018

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: Physician
• Device Catalogue Number: H965103038181
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/10/2018
• Initial Report FDA Received Date: 06/04/2018
• 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