MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD; CATHETER, OXIMETER, FIBEROPTIC

Model Number 774HF75

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

We received one (b)(4) catheter with attached b-d syringe for examination.The reported event of not a clear surface was confirmed.The product should be free of stains, discoloration, smearing and missing parts.The catheter ran cco on the vigilance ii monitor for 5 minutes with no error messages.The thermistor and thermal filament circuit were continuous.The thermistor was found to read 37.1°c when submerged in a 37.0°c water bath.Thermistor temperature reading accuracy is +/-.3° c per the vigilance manual.There were no open or intermittent conditions.The eeprom data was found to be normal, both the stored data and the computed data matched.Resistance value of thermal filament circuit was measured and found to be within specification.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All thru-lumens were tested and found to be patent without any leakage.No visible damage was observed from the returned b-d syringe.The catheter body was found to be free of kinks, indentations, or scratches.Chemistry testing results found similar absorption characteristics when comparing to sebacic acid like material.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.Lot or serial number was not provided, therefore review of the manufacturing records could not be completed.

Event Description

It was reported that what looked like scratches were observed on the catheter body.No patient complications were reported.

Manufacturer Narrative

Per chemistry results performed by the laboratory, sebacic acid was found on the catheter tube.Manufacturing and packaging process, product components and the manufacturing equipment were evaluated to identify if the sebacic acid is used in the manufacturing process.During this assessment no sebacic acid was identified in the manufacturing and packaging process for cco models.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• 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
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 5208745
• MDR Text Key: 30689394
• Report Number: 2015691-2015-03001
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 08/27/2015

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: 774HF75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2015
• Initial Date FDA Received: 11/06/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/24/2015
• 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