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

Model Number X3820S

Device Problem Difficult to Remove (1528)

Patient Problem Hemothorax (1896)

Event Date 09/14/2016

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.No corrective actions will be taken at this time.A review of the manufacturing records indicated that the product met specifications upon release.

Event Description

It was reported that during placement of a presep catheter into the left subclavian access site using the seldinger technique, when the catheter was placed on the guidewire, the guidewire lost its firmness and consistency.The guidewire frayed and stretched, making it difficult to withdrawal.The catheter and guidewire were withdrawn together provoking a vascular lesion that caused a left hemothorax.The patient died during surgery due to heart failure.Unfortunately, the catheter was not available for evaluation.

• 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: brian hurd-servin ; 1 edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6000212
• MDR Text Key: 56484777
• Report Number: 2015691-2016-02934
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: K053609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2016

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 Expiration Date: 03/29/2018
• Device Model Number: X3820S
• Device Lot Number: 60375317
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/05/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2016
• 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 Outcome(s): Other