MAUDE Adverse Event Report: EDWARDS LIFESCIENCES< PR PRESEP - CENTRAL VENOUS OXIMETRY CATHETER

Model Number PRESEP UNKNOWN

Device Problem Detachment Of Device Component (1104)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/05/2016

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.No actions will be taken at this time.

Event Description

It was reported via a journal article that the customer experienced retained guidewire after placement of a central venous catheter via the internal jugular vein.A (b)(6) male was scheduled for an open cholecystectomy and hepatectomy.After induction of anesthesia, a central venous (cv) catheter was inserted via the right internal jugular vein using an ultrasound guide.Chest radiographs showed a retained guide wire in the inferior vena cava immediately after surgery, which was removed by interventional radiologist before the patient emerged from anesthesia.Occurrence date is unknown.The device was not available for evaluation.No patient complications were reported.This information was obtained from the journal of anesthesiology, 2015; 64(10):1085-1087.

• Brand Name: PRESEP - CENTRAL VENOUS OXIMETRY CATHETER
• Type of Device: PRESEP - CENTRAL VENOUS OXIMETRY CATHETER
• 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 ; 9492504386
• MDR Report Key: 5370611
• MDR Text Key: 36098841
• Report Number: 2015691-2016-00165
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2016

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?: No
• Device Operator: Health Professional
• Device Model Number: PRESEP UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/05/2016
• Initial Date FDA Received: 01/15/2016
• 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
• Patient Age: 73