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

Model Number SWAN-GANZ UNKNOWN

Device Problem Separation Problem (4043)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 09/01/2022

Event Type  malfunction  

Manufacturer Narrative

The device is anticipated to be returned for evaluation but has not yet been received.A supplemental will be sent with the evaluation results.A device history record review could not be completed due to an unknown model and lot number.

Event Description

It was reported that during use, while discontinuing of medications from a swan-ganz pacer port, the orange port broke off from the tubing.The initial reporter claimed there was no extra force used when discontinuing the port.There was no sound indicating the port was defective.Blood began leaking out of the tube and to stop the leaking, the tubing was tied in a knot and clamped.It was confirmed there was a scant amount of blood loss.The doctor was notified and there were no orders to discontinue the swan.The catheter was removed on (b)(6) 2022, and a new catheter was not placed.There is no allegation of patient injury.

Manufacturer Narrative

The catheter was not returned for evaluation.Without the 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.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.H3 other text : device not returned.

• 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 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: 15510617
• MDR Text Key: 300871087
• Report Number: 2015691-2022-08174
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SWAN-GANZ UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/26/2022
• 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