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

Model Number 774HF75

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Hematoma (1884)

Event Date 01/01/2017

Event Type  Injury  

Manufacturer Narrative

The product is expected to be returned for analysis; however, it has not yet been received.Upon the return of the product, a supplemental report will be sent with the investigation results.A device history record review was completed and documented that device met all specifications upon distribution.No actions will be taken at this time.

Event Description

As reported, during use, this swan-ganz catheter was leaking blood where the catheter puncture was done.Initially, the placement of swan-ganz catheter with the ava introducer was done without any complications.During the procedure, a hematoma with abnormal thromboelastogram was noticed, which required a transfusion of fresh plasma.Afterwards, a chest x-ray was done and was negative for pneumothorax and pleural effusions, confirming that there was no air density in the subcutaneous tissue.Later, a decrease in the area of the induration at the implantation site of the swan ganz introducer, which had already been removed, was noticed.Possibly due to extravasation of intravenous fluids.There was no other allegation of patient injury.The device is available for evaluation.

Manufacturer Narrative

One 774f75 catheter was returned with an ava3xi attached for evaluation.The report of "blood leakage" was not confirmed.The ava3xi introducer was received attached to the catheter around the 55 cm area of the catheter body tube.The ava was removed from the catheter and seven kinks were observed in the catheter body.All through lumens were found to be patent and did not leak.The balloon inflated clear and concentric and did not leak.The thermistor was found to read 37.1 c when submerged in a 37.0 c water bath on the vigilance ii monitor.Invitro calibration was performed and the catheter failed invitro calibration.Using a high intensity light the optic fibers were found to be leaking light at the kink located at 65 cm proximal of the catheter tip.The catheter ran cco on the vigilance ii monitor for 5 minutes with no error messages.The eeprom data was found to be normal, both the stored data and the computed data matched.A device history record review was completed and documented that device met all specifications upon distribution.No actions will be taken at this time.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: SWAN-GANZ 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: brian hurd-servin ; one edwards way; irvine, CA 92614 ; 9492506423
• MDR Report Key: 6330738
• MDR Text Key: 67437401
• Report Number: 2015691-2017-00370
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K040287
• 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,Followup
• Report Date: 01/25/2017

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: 05/03/2018
• Device Model Number: 774HF75
• Device Lot Number: 60409166
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/25/2017
• Initial Date FDA Received: 02/14/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2016
• 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): Required Intervention
• Patient Age: 51 YR