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

Model Number 746F8

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Perforation (2001); Cardiac Tamponade (2226)

Event Date 07/16/2021

Event Type  Death  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without return of the unit it is not possible to determine if some damage or defect existed on the unit that could have contributed to the event.It is not known if some procedural factors may have contributed to the event.A review of the manufacturing records indicated that the product met specifications upon release.It is unknown if the edwards catheter was suspect in perforation of the vessel.As the details in this case provided by the customer feel that this issue may have been caused by the non-edwards pacing catheter.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 pericardial effusion was observed in a (b)(6) man three hours after a swan-ganz catheter and non-edwards pacing catheter were removed.The patient underwent transfemoral transcatheter aortic valve replacement (tavr) for the native aortic valve, a 29 mm sapien 3 valve was successfully deployed in a targeted position.Hemodynamics were stable and the patient returned to icu with stable condition.Post-op day 2, pericardial effusion was observed three hours after the swan ganz catheter and non-edwards pacing catheter were removed from the patient.Acute changes of vital signs (shock) were observed, so that intubation was introduced and drainage of pericardial fluid was started.When the customer drained, venous blood was aspirated.Hemodynamics became stable.The patient seemed to be improving and was stable, however on post-op day 9 the patient went into cardiopulmonary arrest with a hemoglobin of 4.On post-op day 10, the patient developed non-occlusive mesenteric ischemia (nomi) and disseminated intravascular coagulation (dic).Post-op day 11, the patient expired due to multi-organ failure.Additional details from the physician indicated that the patient was in shock condition due to cardiac tamponade caused by a pacing lead on post-op day 6.It took some time to resume normal hemodynamics, it meant prolonged low cardiac output.It might have affected coagulation system and led increased tendency of bleeding.In addition, heparin and warfarin for the valve thrombosis might have accelerated the bleeding tendency.On pod-6, his arm got swollen due to ecchymoma possibly led by the warfarin.Subsequently, intra-iliopsoas hematoma and decreased hemoglobin were observed.Then it was difficult to control the coagulation system, it would possibly have led the dic, nomi and multiple organ dysfunction syndrome (mof).The customer also reported it was unknown if the patient death was associated with the tavr procedure.The edwards catheter was discarded at the hospital.

• Brand Name: SWAN-GANZ CCOMBO CCO/SVO2/VIP 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
• Manufacturer (Section G): EDWARDS LIFESCIENCES, PR; state rd indus pk 402 km 1.4; anasco PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 12324577
• MDR Text Key: 266657874
• Report Number: 2015691-2021-04701
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K934742
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/04/2022
• Device Model Number: 746F8
• Device Catalogue Number: 746F8
• Device Lot Number: 63187168
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/26/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 85 YR
• Patient Weight: 58