MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ UNKNOWN; CATHETER, FLOW DIRECTED

Model Number SWAN GANZ UNKNOWN

Device Problem Difficult to Remove (1528)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/12/2023

Event Type  malfunction  

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation when received.The lot number was not provided thus a device history record was not reviewed.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 a part of the monthly review.

Event Description

It was reported that saline sprayed from a pinhole on the 100 cc mark of a swan ganz catheter.Event occurred after nurse noticed blood on the pillow of the patient.Nurse attempted to flush the catheter to troubleshoot and found the pinhole.Cv surgeon was called to remove the catheter from the patient.No patient injuries reported.Patient is a 47 year old male, weights 175 lbs, and 6 ft.Patient has a history of gerd, arachnoid cyst, coronary artery disease, and thoracic aortic aneurysm.

Manufacturer Narrative

Per follow up with rep, surgeon did not have to surgically remove the swan.It was pulled at the bedside in a routine manner.This is no longer a reportable event for removal difficulty.Corrections to the h6 codes are as follows health effect impact code was changed to no health consequences or impact.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 a part of the monthly review.

• Brand Name: SWAN GANZ UNKNOWN
• Type of Device: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 17430891
• MDR Text Key: 320249254
• Report Number: 2015691-2023-14936
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: SWAN GANZ UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2023
• 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 Age: 47 YR
• Patient Sex: Male
• Patient Weight: 79 KG