MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR PRESEP - CENTRAL VENOUS OXIMETRY KIT; CATHETER, OXIMETER, FIBEROPTIC

Model Number XA3816HKSAF

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/06/2015

Event Type  malfunction  

Event Description

It was reported that a presep catheter that had been in place in the right internal jugular vein for 6 days broke at the hub near the suture loop anchoring device.A portion of the catheter was retained in the patient.This portion of the catheter was removed by interventional radiology.There were no patient complications noted.

Manufacturer Narrative

We received one presep triple lumen catheter with suture loop and box clamp for examination.The catheter was received broken into 2 pieces at the distal edge of the suture loop/box clamp 3.2cm distal of the backform.The optic fibers appear to have been cut due to the fact that they have been flattened at the break site and the service loop inside the optic connector has not been pulled into the catheter.There is also a kink in the catheter at the distal edge of the backform.Further examination of the catheter found an indentation around the catheter tube 1.3cm proximal of the catheter tip.There is no visible damage to the injection sites or suture loop and box clamp.As stated in the catheter ifu, the incidence of complications increases significantly with indwelling periods of longer than 72 hours.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.The lot number was not provided, therefore review of the manufacturing records could not be completed.

• Brand Name: PRESEP - CENTRAL VENOUS OXIMETRY KIT
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 4809447
• MDR Text Key: 18876159
• Report Number: 2015691-2015-01257
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K060093
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 05/06/2015

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
• Device Model Number: XA3816HKSAF
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/06/2015
• Initial Date FDA Received: 06/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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