MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR UNKNOWN

Model Number CCOCATHUNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

Without the return of the product, it is not possible to determine if damages or defects exist on the product.The lot number was not provided; therefore, a review of the manufacturing records could not be completed.An engineering evaluation has been completed and no manufacturing non-conformances nor root causes were identified.Complaint histories for all reported events are reviewed against trending control limits and any excursions above the control limits are assessed and documented as part of the monthly review.Complaints incidence will continue to be monitored, and applicable actions will be taken as required.There was no allegation of specific device non-conformance, and the perforated right lower lobe and the pseudoaneurysm were most likely procedurally related.

Event Description

It was reported through a literature review in radiology case reports, successful percutaneous embolization of an intraoperative swan ganz catheter-related pulmonary artery injury, that a swan ganz pulmonary artery catheter caused perforation and a pseudoaneurysm of the right lower lobe of the lung.The patient was a 59 year old female, with a diagnosis of chronic ischemic heart disease that underwent a coronary arterial bypass graft, cabg, in the operating room.After completion of the coronary bypass graft surgery, while the patient was still on bypass, anesthesia noticed bloody secretions in the endotracheal tube, as well as difficult ventilation.An emergent bronchoscopy was performed, identifying the source of bleeding was in the right lower lobe of the lung, and successful hemostasis was achieved utilizing 2 kittner sponges.The patient was then removed from bypass and transferred to the cicu, where a cat scan identified a right lower lobe pseudoaneurysm.The patient was transferred to interventional radiology, where a successful endoscopic coil embolization was performed, as well as removal of the sponges.The patient was discharged home successfully after surgery and consequent interventions.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• 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: 15959872
• MDR Text Key: 305269165
• Report Number: 2015691-2022-09929
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: CCOCATHUNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/21/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 59 YR
• Patient Sex: Female