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

Model Number 774F75

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Respiratory Distress (2045); Thrombosis (2100)

Event Date 02/04/2020

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 on the 4th day post-off-pump coronary artery bypass (opcab) surgery, the patient experienced respiratory distress.A ¿thrombosis was found at the right upper site¿.It was not known if the customer was referring to the insertion site or the internal location of the swan-ganz catheter.Per a follow-up discussion with the anesthesiologist, he stated that the right side is where the swan-ganz was inserted, so was not sure if anything related to the swan-ganz may have caused the thrombosis or if the swan-ganz catheter could have been ¿inserted too deep¿, causing injury.It was also noted that after the surgery, the swan-ganz was ¿removed slightly before moving the patient to the icu¿.The patient outcome and current status are unknown.Patient demographics were requested and unknown.The lot number was unknown.

Manufacturer Narrative

In regards to this complaint in which a patient developed a pulmonary thrombosis after opcab, additional information was obtained.During treatment for this condition, the patient received medication and fluid therapy for breathing difficulties.The patient did recover without incident.In addition, the treating physician stated that the use of the product did not cause the resulting thrombosis.

Manufacturer Narrative

Further follow-up confirmed the device was not available for evaluation.Without the return of the product, it is not possible to determine if damages or defects existed on the product, nor could a root cause or potential contributing factors be identified.Additional information obtained noted that the patient was doing well.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.As stated in the ifu, spontaneous tip wedging may occur.The catheter may migrate into the distal pulmonary artery and spontaneous tip wedging may occur.To avoid this complication, pulmonary artery pressure should be monitored continuously with a pressure transducer and display monitor.Forward advancement should never be forced if resistance is encountered.Other complications include right bundle branch block, complete heart block, tricuspid and pulmonic valve damage, thrombocytopenia, pneumothorax, thrombophlebitis, nitroglycerin absorption, and thrombosis.In this case the patient was said to be doing well after the incident.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 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: 9717220
• MDR Text Key: 194490944
• Report Number: 2015691-2020-10566
• 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,Followup,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 774F75
• Device Catalogue Number: 774F75
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/23/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other