MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR PRESEP CATHETER

Model Number PRESEP UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 08/21/2015

Event Type  Injury  

Manufacturer Narrative

No product was returned for evaluation; it was discarded at the hospital.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

After completion of surgery for aortic valve replacement, the patient was being moved from the surgical table to the bed when the presep catheter was caught on the transfer board and pulled out from the 13cm mark to the 6cm mark.The patient had been receiving ¿dobupum¿ via the presep catheter, and experienced a drop in blood pressure due to lost medication.The patient was given ¿neo-synesin¿ and the blood pressure stabilized.The patient was moved to the ccu and the presep catheter was replaced.There were no further patient complications reported.

• Brand Name: PRESEP CATHETER
• Type of Device: PRESEP 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: 5082615
• MDR Text Key: 25989010
• Report Number: 2015691-2015-02431
• 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
• Report Date: 08/21/2015

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 Model Number: PRESEP UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/16/2015
• 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