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

Model Number 774F75

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2017

Event Type  malfunction  

Manufacturer Narrative

One catheter with attached monoject 1.5 cc limited volume syringe and a pressure tubing set was returned for evaluation.Proximal injectate lumen hub with a non-edwards stop cock was also returned.A non-edwards contamination shield with introducer was located on the catheter body between 0.5 cm and 76 cm proximal from the catheter tip.Clotted blood was observed inside the catheter.Contamination shield with introducer was removed for evaluation.Proximal injectate lumen hub was completely detached from the extension tube.The cross-surface at the extension tube was rough and blood was observed inside the extension tube.The cross-surface at the hub was smooth and even.The proximal injectate lumen was occluded with clotted blood and it was not able to remove the blood with warm water or a guidewire.The pa distal lumen was patent without any leakage or occlusion.Catheter body was found collapsed at 5.5 cm proximal from the catheter tip.The balloon inflated clear, concentric and remained inflated for more than 5 minutes without leakage.No visible damage or abnormality to the balloon or returned syringe was observed.Balloon inflation test was performed using returned syringe with 1.5 cc air.Visual examination was performed under microscope at 20x magnification and with the unaided eyes.A device history record review was completed and documented that device met all specifications upon distribution.Customer report of proximal injectate lumen hub detachment was confirmed during the evaluation as the proximal injectate lumen hub was completely detached from the extension tube.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint and implement any necessary corrective actions.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 inspect all products before usage.These products are used by highly trained clinicians, experienced in identifying and mitigating any hazards that arise during use.The catheter can be exchanged for another one, causing a minor delay in treatment or monitoring.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.(b)(4).

Event Description

It was reported that the hub of the proximal injectate lumen became detached during use.Blood back flow was observed, so the lumen was clamped.The clinician continued to use the catheter until the patient moved to icu.The amount of blood leakage is unknown.There was no report of patient harm or injury.Inquired of patient demographics.Only gender was able to be obtained.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• 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: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 6555943
• MDR Text Key: 74793508
• Report Number: 2015691-2017-01264
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/14/2017

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: 10/25/2018
• Device Model Number: 774F75
• Device Lot Number: 60605417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/14/2017
• Initial Date FDA Received: 05/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/03/2016
• 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