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

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Low Oxygen Saturation (2477)

Event Date 09/23/2020

Event Type  Injury  

Manufacturer Narrative

It is unknown whether the product is available for evaluation.A supplemental report will be forthcoming with the evaluation and device history results if the device is received.It is unknown if the device or procedural factors contributed to the decline in patient condition.The model number and lot number is unknown.Follow up is on-going to get more information from the customer.As both the model and lot numbers are unknown, the udi number is not available.

Event Description

It was reported that prior to insertion of the right internal jugular of this swan-ganz catheter via introducer, the catheter was placed to flush bag.Ports were flushed and balloon was inflated without difficulty.The swandom (sheath) was applied but the balloon inflation was not completed after applying the contamination shield.The swan was inserted.The certified registered nurse practitioner inflated the balloon with resistance.The balloon deflated and the swan was inserted farther.The swan waveform and number did not appear correct so the swan was removed.Upon removal of the swan the balloon was not present on the end of the catheter.It is difficult to ascertain if there is a small part of the balloon on the tip, but it appears as if the entire balloon is non-existent.A new swan catheter was readied and inserted by the crnp.As a new swan was being inserted the rn noted decreasing o2 saturation.Saturation continued to decrease to 60's-70's and the heart rate decreased to 50's.The patient became unresponsive.Bagged with 100% fio2.Anesthesia intubated without difficulty.The patient exhibited decreased blood pressure with continued decrease heart rate.The patient was treated with levo drip, low dose epi push, and one amp bicarb given with good blood pressure response.The patient status is unknown.Follow up is ongoing for current patient condition.

Manufacturer Narrative

This is a correction for the event date which occurred (b)(6) 2020.Received in medsun number: (b)(4).

• Brand Name: SWAN-GANZ CATHETER 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; 1 edwards way; irvine CA 92614
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614
• MDR Report Key: 12652686
• MDR Text Key: 277363068
• Report Number: 2015691-2021-05763
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/19/2021
• 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): Required Intervention
• Patient Age: 79 YR
• Patient Sex: Female