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

Model Number 774F75

Device Problem Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 02/24/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 774f75 catheter with a 1.5cc syringe.The balloon was found to be ruptured around the circumference in the central area of the balloon latex.The latex edges did not seem to match at the ruptured region.All through lumens were patent without any leakage or occlusion.No other visible damage was observed from the catheter body.A device history record review was completed and documented that the device met all specifications upon distribution.The customer report of a balloon issue 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 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 prior to insertion, the balloon on a swan-ganz catheter burst.A new device was used without issue.There was no patient injury.Patient demographics were requested and are unknown.

Manufacturer Narrative

Corrected data: f10, h6.Reference capa-20-00141.

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBEROPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8481163
• MDR Text Key: 140913583
• Report Number: 2015691-2019-01168
• 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: 02/26/2019

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: 02/28/2020
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Device Lot Number: 61286357
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2019
• Initial Date Manufacturer Received: 03/31/2019
• Initial Date FDA Received: 04/03/2019
• Supplement Dates Manufacturer Received: 07/23/2020
• Supplement Dates FDA Received: 01/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1