MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER; CATHETER, FLOW DIRECTED

Model Number SWAN GANZ UNKNOWN

Device Problems Break (1069); Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problems Death (1802); Sepsis (2067); Septic Shock (2068); Device Embedded In Tissue or Plaque (3165)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product, nor can any manufacturing nonconformance, failure mode, root cause, or potential contributing factors be identified.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.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.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.In this instance, the physician decided to leave the retained portion of the broken swan-ganz catheter in the patient without any further interventions to retrieve it.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 on (b)(6) 2019 during use of a swan-ganz catheter in a patient undergoing re-operation of the aortic and tricuspid valves, the anesthesiologist had some issues during placement of the catheter and ¿couldn¿t place it in a right way¿.Additionally, he didn¿t get a measure of cardiac output.The surgeon replaced the aortic and tricuspid valves ¿without inconvenience¿ using a mechanical aortic valve prothesis and a biological valve for the tricuspid.After the procedure, the anesthesiologist tried to remove the swan-ganz catheter, but the catheter was ¿kind of stuck¿ so he ¿tried harder to remove it¿ and ¿after many attempts, the swan-ganz broke.¿ due to the complexity of the procedure performed, the surgeon ¿decided to leave the broken part in the patient.¿ the next day, the patient was moved to the cath lab with the intent to remove the remaining portion of the catheter; however, the physicians could only remove a portion of the remaining part and ¿decided to leave the rest of it in the patient.¿ in the following days the patient was diagnosed with septic shock and died on (b)(6) 2019.The product was discarded and is not available for evaluation.The model and lot number are unknown.Patient demographics were requested and not provided.

Manufacturer Narrative

Per additional follow-up, new information on this event was obtained.The suspect device model number, as well as, partial patient demographics and updated hospital information were obtained.It was clarified that prior to insertion, the balloon and lumens on the model 774f75 swan-ganz catheter had been checked without any issues noted.At the time of insertion, there was some resistance noted with the introducer but no resistance with the dilator.Reportedly, the catheter could not be placed properly; however, this was only a ¿clinical suspicion¿ and could not be confirmed via imaging.From the beginning of the case, no values were displayed, cardiac output (co) and svo2 could not be confirmed, and only one pressure curve was registering.No error messages were displayed.The catheter did not sustain any known damage during the case, ¿at least not intentionally or in a way to be detected¿.It was decided at the end of the case that due to the catheter malfunctioning (as described above), it would be removed.Echocardiography was performed prior to removal and the result was negative for a clot or catheter looping.The device broke into two pieces ¿at the metallic part, around 20-25cm¿ from the tip.It was originally reported that the 46-year-old female patient expired due to septic shock; however, it was clarified on follow-up that the catheter pieces that were left inside of the patient were not the cause of her endocarditis and septic shock.

Manufacturer Narrative

Reference capa-20-00141.

Manufacturer Narrative

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

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2 THERMODILUTION CATHETER
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• MDR Report Key: 8881466
• MDR Text Key: 154165192
• Report Number: 2015691-2019-02979
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• PMA/PMN Number: K924452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 07/26/2019

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?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWAN GANZ UNKNOWN
• 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): Death; Other