MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR DISPOSABLE PRESSURE TRANSDUCER; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number DPTUNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Arrhythmia (1721)

Event Date 03/08/2018

Event Type  Injury  

Manufacturer Narrative

One double dpt kit was returned for examination.No malfunction or damage was found during the examination of the returned pressure monitoring kit.The kit was primed and flushed without any visible indication of occlusion or flow restriction.In addition, there no leakage was noticed from the kit during a leak test.Both dpt sensors zeroed and sensed pressure accurately on a pressure monitor.The reported event could not be confirmed or replicated during the analysis, as the device responded appropriately during functional testing.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.No further actions will be taken at this time.Lot number was not provided, therefore review of the manufacturing records could not be completed.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 are well described in the literature.In the swan ganz ifu that was used with this system setup, it is noted that cardiac arrhythmias may occur during insertion, withdrawal and repositioning of the catheter, but are usually transient and self-limiting.Premature ventricular contractions are the most commonly observed arrhythmia.Ventricular tachycardia and atrial tachycardia have been reported.In the complications section of the dpt ifu it is noted that air can enter the patient through stopcocks that are inadvertently left open, from accidental disconnection of the pressure setup, or from residual air bubbles into the patient.Central venous pressure catheters have been associated with air embolism.The patient experienced a tachyarrhythmia during the procedure.In this instance, the patient required two electrical shocks to be stabilized.It is unknown if user or procedural factors contributed to the stated event.With the 4 devices involved in this event, all evaluations were no fault found.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.Mdr# swan-ganz catheter 2015691-2018-02118 mdr# ava introducer 2015691-2018-02087.

Event Description

It was reported that despite several attempts to aspirate a mixed venous saturation (svo2) sample from the proximal injectate lumen on a swan-ganz catheter, there was only 40cc of air return and no blood.The sample was drawn from an approximately 10cm long section of extension tubing connected to a 3-way stopcock that had been added to the lumen.The stopcock was also connected to another port that went to a disposable pressure transducer.The customer states that the device was correctly ¿purged and permeability was also verified.¿ air was also found in other lumens that were being used for different treatments, such as sedation and catecholamine; however, blood sampling was accomplished without any issue through the pulmonary artery lumen.Following the aspiration of air, the catheter was immediately removed and precautions were taken to avoid any consequences that might occur from an air embolism.Updated information from the hospital also reported that the patient experienced a tachyarrhythmia requiring two ¿electric shocks.¿ the patient outcome was reported as good.The hospital could not find a clear explanation of the problem, despite performing an in-vitro test with the swan-ganz catheter and an ava introducer.The customer returned 2 disposable pressure transducers, a swan ganz catheter and an ava introducer for evaluation.All 4 devices will be reported and mdrs cross referenced.

• Brand Name: DISPOSABLE PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; parque industrial de itabo; carr. sanchez km 18.5; haina, san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 7579963
• MDR Text Key: 110448458
• Report Number: 2015691-2018-02188
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 05/14/2018

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 Model Number: DPTUNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/22/2018
• Initial Date FDA Received: 06/07/2018
• 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
• Patient Outcome(s): Life Threatening
• Patient Age: 64 YR
• Patient Weight: 92