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

Model Number 744HF75

Device Problem Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/22/2016

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.

Event Description

It was reported that during testing, prior to insertion, the swan ganz catheter ¿bent over itself¿.The clinician chose to use the catheter, and after the balloon was inflated inside the patient, the catheter would not advance.A decision was made to remove the swan-ganz catheter out of the patient and during this process the catheter was stuck in the introducer.It was necessary to remove the introducer and the catheter from patient.A st.Jude¿s introducer was used but it was not known the model or size.Per the customer opinion, the st.Jude¿s introducer may have contributed to the problem, not the swan-ganz catheter.Another st.Jude¿s introducer was inserted at the same insertion point.A new swan-ganz catheter from the same model was used with success.It was not known if the st jude introducer was of the same model.There was no patient consequences reported.Customer confirmed that no product was available for evaluation as both the introducer and the swan-ganz catheter were discarded.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER WITH AMC THROMBOSHIELD
• Type of Device: CATHETER, FLOW DIRECTED
• 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: 5970807
• MDR Text Key: 55445482
• Report Number: 2015691-2016-02820
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K924452
• 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
• Report Date: 07/22/2016

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: 02/09/2017
• Device Model Number: 744HF75
• Device Lot Number: 60112340
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/22/2016
• Initial Date FDA Received: 09/22/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/13/2015
• 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
• Treatment: NON-EDWARDS INTRODUCER