MAUDE Adverse Event Report: BARD EYNOSA S.A DE C.V HEMOSPLIT XK LONG-TRM HEMODIALYSIS CATHETER 16F STANDARD

Catalog Number 5683730

Device Problems Material Fragmentation (1261); Difficult to Insert (1316); Kinked (1339)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/01/2014

Event Type  Injury  

Event Description

On (b)(6) 2015 per medwatch: reportedly a portion of a guidewire broke off during the placement of an internal jugular hemodialysis catheter.The device fragment was found to be within the svc and right atrium.The guidewire 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 guidewire 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.But x-ray the retained part of the catheter may be 8 to 16cm in length.Per radiologist an accurate measurement is not available per x-ray.Diagnosis for use renal failure - hemodialysis.Since the broken guidewire was not noted during the procedure the product was not retained, therefore unsure which of the two guidewires used above during the procedure broke of were accidentally sheard off.(b)(6).Mw ref #5040084.

Manufacturer Narrative

The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of rexl1018 showed no other similar product complaint(s) from this lot number.

• Brand Name: HEMOSPLIT XK LONG-TRM HEMODIALYSIS CATHETER 16F STANDARD
• Manufacturer (Section D): BARD EYNOSA S.A DE C.V; reynosa tamaulipas ; MX
• Manufacturer (Section G): BARD REYNOSA S.A DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas ; MX
• Manufacturer Contact: christy chandonia ; 605 north 5600 west; salt lake city, UT 84116 ; 8015224969
• MDR Report Key: 4798520
• MDR Text Key: 5880892
• Report Number: 3006260740-2015-00229
• Device Sequence Number: 1
• Product Code: MSD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K033294
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/15/2015

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
• Device Operator: Health Professional
• Device Catalogue Number: 5683730
• Device Lot Number: REXL1018
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/06/2015
• Event Location: Home
• Date Report to Manufacturer: 05/04/2015
• Initial Date Manufacturer Received: 05/15/2015
• Initial Date FDA Received: 05/22/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2013
• 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
• Treatment: NI ON MEDWATCH
• Patient Outcome(s): Required Intervention