MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER

Model Number 774F75

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/24/2017

Event Type  malfunction  

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.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.

Event Description

It was reported that the tip of the swan ganz catheter was found to be torn during balloon inflation testing, prior to use.Additionally, it was noted that fragments of the damaged balloon had separated.Patient demographic information requested but unavailable.There was no allegation of patient injury.

Manufacturer Narrative

Based on eeprom data received on the device, a lot number was discovered.A device history records review was completed and documented that the device met all specifications upon distribution.(b)(4).

Manufacturer Narrative

Our product evaluation laboratory received one swan-ganz catheter with a monoject limited volume syringe and contamination shield.As received, the contamination shield was detached from the proximal tuohy borst connector.The balloon inflated clear and concentric and remained inflated for 5 minutes without leakage.All through lumens were patent without any leakage or occlusion.No visible damage was observed from catheter body or returned syringe.The report of a balloon issue was not confirmed, as the device responded appropriately during functional testing.There was no evidence of a manufacturing nonconformance.No actions will be taken at this time.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.It is common clinical practice to check balloon integrity by inflating it to the recommended volume in order to detect any asymmetry or leakage condition before use of the catheter.When there is separation of the balloon or fragments from the pulmonary artery catheter, the retained fragments will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated.It is unknown if user or procedural factors contributed to this event.Complaint histories for all reported events are reviewed against trending control limits on a monthly basis, and any excursions above the control limits are assessed and documented as part of this monthly review.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION 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 ; 9497564386
• MDR Report Key: 6882724
• MDR Text Key: 87639296
• Report Number: 2015691-2017-03010
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2017

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: 11/03/2018
• Device Model Number: 774F75
• Device Lot Number: 60615209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/25/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 10/31/2017; 12/11/2017
• Supplement Dates FDA Received: 11/12/2017; 12/12/2017
• 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