MAUDE Adverse Event Report: EDWARDS LIFESCIENCES SWAN-GANZ PACEPORT OXIMETRY TD CATHETER; CATHETER, OXIMETER, FIBEROPTIC

Model Number 780F75M

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2016

Event Type  malfunction  

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.The ifu for this product states keep pressure monitoring lumens patent by intermittent flush or continuous slow infusion with heparinized saline solution.Potential risks associated with the use of swan-ganz catheters include thrombus formation, plaque dislodgement, and embolization that may result in myocardial infarction, stroke, distal peripheral occlusion, and/or death.The duration of catheterization should be the minimum required by the patients clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.Invasive procedures involve some patient risks.Although serious complications are relatively uncommon, the physician is advised, before deciding to insert or use the catheter, to consider the potential benefits in relation to the possible complications.The techniques for insertion, methods of using the catheter to obtain patient data information, and the occurrence of complications is well described in the literature.

Event Description

It was reported that when withdrawing 1 unit of blood from the cordis and re-infusing it after patient comes off bypass, clots are seen in the collection bag.The clots were long and therefore and believed to be forming in the tubing.They were not formed in the collection bag.In order to reduce clot formation , the physician started actively withdrawing blood from the cordis.The physician doesn't wait for gravity to work.Inquired of patient demographics, unable to be obtained.

• Brand Name: SWAN-GANZ PACEPORT OXIMETRY TD CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES; 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: 6103256
• MDR Text Key: 59978452
• Report Number: 2015691-2016-03375
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905458
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 10/23/2016

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/12/2018
• Device Model Number: 780F75M
• Device Lot Number: 60561858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2016
• Initial Date FDA Received: 11/15/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/16/2016
• 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