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

Model Number 777F8

Device Problems Deflation Problem (1149); Material Rupture (1546)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 01/24/2019

Event Type  malfunction  

Manufacturer Narrative

Our product evaluation laboratory received one model 777f8 catheter with an attached 1.5cc limited volume syringe and a non-edwards contamination shield.The balloon was found to have ruptured at approximately 0.20 inches from the distal end of the proximal bond to the proximal end of the distal bond of the balloon.The balloon latex showed signs of latex deterioration.The edges of the latex appeared to match up at the ruptured site.All through lumens were patent without any leakage or occlusion.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.The customer report of "balloon on swan-ganz catheter ruptured" was confirmed on evaluation.An engineering evaluation was 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.Balloon deflation difficulty can result in an occlusion of blood flow and possible distal ischemia.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.Additionally, the duration of catheterization should be the minimum required by the patient¿s clinical state since the risk of thromboembolic and infectious complications increases with time.The incidence of complications increases significantly with indwelling periods longer than 72 hours.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 the balloon on a swan-ganz catheter ruptured during use.The swan-ganz catheter was inserted on (b)(6) 2019 following percutaneous coronary intervention (pci) for an st elevation myocardial infarction (stemi).In the early morning of (b)(6) 2019, when the rn went to inflate the balloon to obtain a wedge pressure, the balloon would not passively deflate; however, a questionable wedge waveform was seen, so the balloon was pulled back about 10cm and a stat chest x-ray was obtained.The rn, the charge rn, and the ¿ccu¿ physician made the decision to immediately remove the swan-ganz catheter due to concern for balloon rupture.The catheter was successfully removed without complication.No changes in the patient¿s condition were reported afterward.Patient demographics were requested and not provided.The lot number of the suspect device was unknown.

Manufacturer Narrative

The product lot number was discovered via review of eeprom data.A device history record review was completed and documented that the device met all specifications upon distribution.Udi (b)(4).

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO V CCO/SVO2/CEDV/VIP 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: 8376446
• MDR Text Key: 137836809
• Report Number: 2015691-2019-00667
• 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: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 01/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/09/2020
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 61352627
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1