MAUDE Adverse Event Report: BARD BARD HEMOSPLIT XK

Lot Number REXL1018

Device Problems Bent (1059); Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212); Kinked (1339); Failure to Advance (2524)

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

Event Date 12/01/2014

Event Type  Injury  

Event Description

Portion of a guide wire broke off during the placement of an internal jugular hemodialysis catheter.The device fragment was found to be within the superior vena cava and right atrium.The guide wire was not noted to have broken during the initial procedure.The device fragment was found on fluoroscopy on (b)(6) 2014 when another dialysis catheter was placed as the one placed on (b)(6) 2014 was not functioning well.After multiple consultants with an interventional radiologist and a cardiothoracic surgeon the patient was transferred on (b)(6) 2014 to a tertiary medical center for endovascular removal of the device fragment.The fragment was successfully removed without further complications on (b)(6) 2014.The procedure performed on (b)(6) 2014 was difficult.The surgeon tried to insert in right jugular and was unable so switched to left jugular.It was then noted that the guide wire did "kink" and was returned "bent".Neither the physician or the staff noted that the end of the catheter had broken off or sheared off.By x-ray the retained part of the catheter may be 8 to 16 cm in length.Per radiologist an accurate measurement is not available per x-ray.Diagnosis for use: renal failure - hemodialysis.Since the broken guide wire was not noted during the procedure the product was not retained, therefore, unsure which of the two guide wires used above during the procedure broke of were accidently sheared off.

• Brand Name: BARD HEMOSPLIT XK
• Type of Device: BARD HEMOSPLIT XK
• Manufacturer (Section D): BARD
• MDR Report Key: 4402794
• MDR Text Key: 5121276
• Report Number: MW5040084
• Device Sequence Number: 2
• Product Code: MSD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/06/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2015
• Device Lot Number: REXL1018
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 32 YR
• Patient Weight: 65