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

Model Number 774F75

Device Problem Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/01/2020

Event Type  malfunction  

Manufacturer Narrative

One 774f75 catheter with a 1.5 syringe and a non-ew contamination shield were returned for examination.The reported event of balloon deflation issue could not be confirmed as per condition of return, however the customer report of balloon ruptured was confirmed.As received, the balloon was found to be ruptured and the rupture edge did not appear to match up.No other visible damage was observed from the catheter body or the returned syringe.All through lumens were patent without any leakage or occlusion.Lot number was not provided, therefore review of the manufacturing records could not be completed.An investigation has been initiated to consider any potential manufacturing factors that may have contributed to this complaint.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 standard 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 fragment will embolize to the lungs.Due to the large surface area of the pulmonary vasculature, this is generally well tolerated, but can lead to complications such as infection or small infarction.Pulmonary complications may result from improper inflation technique.To avoid damage to the pulmonary artery and possible balloon rupture, the balloon should not be inflated above the recommended volume.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.

Event Description

It was reported that during use in a patient of this swan-ganz catheter, the balloon could not be deflated with the syringe attached to the gatevalve.The customer pulled it back and the balloon ruptured.It was specified that this swan ganz was tested before use with patient and there was no issue.There was no vessel injury due to the incident.There was no allegation of patient injury.The device was available for evaluation.Patient demographics were unable to be obtained.

Manufacturer Narrative

As part of the manufacturing process, a 100% of the units go through a balloon inflation and visual inspection process.Personnel acknowledgement was conducted at the manufacturing site to prevent recurrence of this type of complaint.A review of the manufacturing records indicated that the product met specifications upon release.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETE
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco PR
• MDR Report Key: 11121512
• MDR Text Key: 227070942
• Report Number: 2015691-2021-00020
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2022
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 63144365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/21/2020
• Date Manufacturer Received: 02/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1