MAUDE Adverse Event Report: EDWARDS LIFESCIENCES, PR SWAN-GANZ CCOMBO V; CATHETER, OXIMETER, FIBER-OPTIC

Model Number SWAN GANZ UNKNOWN

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/22/2023

Event Type  malfunction  

Event Description

It was reported that during use with this swan-ganz catheter, the svo2 chip had become disconnected from the encapsulated tubing exposing the internal wiring.The wire seemed frayed.The svo2 results were still showing on the monitor, but they were lower than expected given the clinical situation.There was no patient injury.

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 was unable to be completed as the lot number is unknown.H3 other text : device not returned.

Manufacturer Narrative

One 777f8 catheter with monoject limited volume syringe and non-edwards contamination shield was returned for examination.The reported issue of the svo2 chip being disconnected was confirmed.The reported issue of the inaccurate svo2 readings were unable to be evaluated due to the broken optic fiber.As received, the optic extension tube was detached from boot connector and the optic connector.Both optic fibers and kevlar fibers were broken.There was adhesive trace on the extension tube.Invitro calibration was unable to be performed due to the broken optic fibers.All through lumens were patent without any leakage or occlusion.The balloon inflated clear and concentric and remained inflated for five minutes without leakage.The reported issue of inaccurate svo2 readings were unable to be evaluated due to the broken optic fiber.An image evaluation was performed.Two images were reviewed.Both images showed the optic extension tube was detached from the boot connect and the optic connector.The kevlar fiber was broken while the optical fibers appeared intact.An engineering evaluation was initiated to assess for any manufacturing related processes which could be correlated to the complaint.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.Correction: updates to the h6 codes are as follows: type of investigation was changed to testing of device from same lot/batch retained by manufacturer.Investigation findings was changed to no finding available.Investigation conclusions was changed to cause not established.

• Brand Name: SWAN-GANZ CCOMBO V
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• 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; state rd indus pk 402 km 1.4 PR 00610
• Manufacturer Contact: jessica atallah ; 1 edwards way; irvine, CA 92614 ; 9492500294
• MDR Report Key: 17733204
• MDR Text Key: 323510152
• Report Number: 2015691-2023-15884
• Device Sequence Number: 1
• Product Code: DQE
• 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: 11/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/23/2023
• Initial Date FDA Received: 09/12/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1