MAUDE Adverse Event Report: EDWARDS LIFESCIENCES PR SWAN GANZ CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER; CATHETER, OXIMETER, FIBER OPTIC

Model Number 777F8

Device Problem Inadequacy of Device Shape and/or Size (1583)

Patient Problem Perforation (2001)

Event Date 03/29/2023

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation nor were any images provided of the event.Without return of the unit it is not possible to confirm if the reported bent tip contributed to the event or if other damages or defects exist on the product.Multiple attempts were made to obtain additional details related to the reported event.However the hospital has declined to cooperate with additional investigation.A dhr report has been ordered.A supplemental report will be forthcoming with the device history results when received.Further evaluation regarding related quality issues is under investigation.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 by an edwards employee that a customer called alleging a perforated ventricle due to a bent tip related to the fca 91868.Upon follow up with the customer, it was reported that during a cabg procedure, one model 777f8 swan ganz catheter pierced the patient ventricle, requiring immediate removal.The catheter was noted to be protruding into the wall of the right ventricle after the sternotomy.However, it did not completely protrude through the ventricle.The catheter was then removed and a new catheter was inserted.The site was watched throughout the procedure with bruising noted.No additional patient complications were reported.Additionally the cnra reported that the catheter was from either lot 64584950 or 64470780.The devices were not available for return.Medwatch (b)(4) was also received and provided patient demographics information and confirmation that the correct lot number is 64584950.No other additional information of the event was provided in the report.

Manufacturer Narrative

Updates to the h6 codes are as follows investigation findings was changed to no findings available and investigation conclusions was changed to cause not established.A device history record review was completed and documented that device met all specifications upon distribution.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 CCOMBO V CCO SVO2 CEDV VIP THERMODILUTION CATHETER
• Type of Device: CATHETER, OXIMETER, FIBER OPTIC
• 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: 16892106
• MDR Text Key: 314804781
• Report Number: 2015691-2023-12852
• Device Sequence Number: 1
• Product Code: DQE
• UDI-Device Identifier: 00690103146554
• UDI-Public: (01)00690103146554(17)240829(11)220830(10)64584950
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date: 05/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 64584950
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/31/2023
• Initial Date FDA Received: 05/08/2023
• Supplement Dates Manufacturer Received: 05/30/2023
• Supplement Dates FDA Received: 05/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/30/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: FCA 91868
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 78 YR
• Patient Sex: Female