MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ THERMODILUTION PACEPORT CATHETER; ELECTRODE, PACEMAKER, TEMPORARY

Model Number 931F75

Device Problems Backflow (1064); Material Separation (1562)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 08/06/2019

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 during use of a swan-ganz catheter, the "pa lumen came apart from the connection where all the lumens meet".There was back flow of blood with an estimated blood loss of 50ml.The catheter needed to be discontinued and replaced.The catheter had been in use for 2 days at the time of the event.There was no known cause or specific incident known to have caused or contributed to the detachment.There was no allegation of patient injury.The lot number is unknown.

Manufacturer Narrative

Medwatch report #mw5088856 was received.Per the report, the customer reported that the pa / distal port "spontaneously disconnected from the main plastic (triangle) plastic piece where all lumens meet." it was also reported that the nurse was in the patient's room at the time, so the issue was immediately recognized and intervened upon.A new swan-ganz catheter was inserted at a different site.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.In this case, the patient required a new stick to insert a new catheter.

Manufacturer Narrative

Additional evaluation of the swan-ganz pacing catheter was performed by the product evaluation lab.The length of the pa/distal extension tube was measured to be 8.9 inches.The inflation lumen extension tube was found to be inserted 0.165 inches beyond the insert.The thermistor lumen extension tube was found to be inserted 0.218 inches beyond the insert.

Manufacturer Narrative

Our product evaluation laboratory received one paceport catheter with a contamination shield.The distal connector of the contamination shield was missing.The label on the backform was missing.The pa/distal extension tube was detached from the backform.The distal end of the pa/distal extension tube was flush with the distal end of the insert.Per specifications, the extension tube should be inserted 0.240 inches beyond the insert.The balloon inflated clear and concentric and remained inflated for 5 timed minutes without leakage.All other through lumens were patent without any leakage or occlusion.No visible damage was observed from the catheter body.The customer report of "the pa lumen came apart" was confirmed on evaluation.An engineering evaluation has been initiated to assess for any manufacturing-related processes which could be correlated to the complaint.Invasive procedures inherently involve some patient risks.Although serious complications associated with pulmonary artery catheters are relatively uncommon, the physician is advised before deciding to use the catheter to consider and weigh the potential benefits and risks associated with the use of the catheter against alternative procedures.The general risks and complications associated with indwelling catheters are well documented in the literature.It is standard clinical practice to inspect these devices prior to use on a patient during set-up and flushing.In the event that this issue is not noted before use, the catheter can be exchanged easily 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.

Manufacturer Narrative

Reference capa-20-00141.

• Brand Name: SWAN-GANZ THERMODILUTION PACEPORT CATHETER
• Type of Device: ELECTRODE, PACEMAKER, TEMPORARY
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8881450
• MDR Text Key: 154115740
• Report Number: 2015691-2019-02976
• Device Sequence Number: 1
• Product Code: LDF
• Combination Product (y/n): N
• PMA/PMN Number: K803058
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 931F75
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 116