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

Model Number 777F8

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Type  Injury  

Event Description

It was reported, during an aortic valve replacement, a swan ganz cco catheter was accidentally sewn in the heart.The suture was cut during procedure and the catheter was released.Additionally, blood leaked from the connection between the optical module connector and an oximetry cable.The customer assumed that a shunt might have been created between the distal lumen and optical fiber lumen when the catheter was sutured and requested an investigation on the catheter.The catheter was removed, and another catheter was not used.The patient was an adult.It was unknown if additional blood transfusion was required due to the leakage, but no injury or complication occurred.Date of event is unknown.

Manufacturer Narrative

The device evaluation is anticipated.However, the complaint cannot not be confirmed without the completion of a product evaluation.A supplemental report will be forthcoming with the evaluation and device history results when received.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.

Manufacturer Narrative

The reported event of blood leakage issue was confirmed.As received, blood was visible inside optical module connector.A slit was noticed on catheter body at middle of thermal filament area.The slit was approximately 0.09inches in length and 18cm proximal from the tip.Thermal filament cover was torn at the slit but thermal filament circuit was continuous.Leak test indicated that the slit entered distal and optical lumens.All other through lumens were patent without any leakage or occlusion.The balloon inflated clear, concentric and remained inflated for more than 5 mins.Without leakage.No other visible inconsistencies were noticed from the rest of the unit.Further evaluation regarding supplier related quality issues is under investigation.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
• Type of Device: CATHETER, OXIMETER, FIBER-OPTIC
• Manufacturer (Section D): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer (Section G): EDWARDS LIFESCIENCES PR; state rd indus pk 402 km 1.4; anasco, puerto rico
• Manufacturer Contact: samantha eveleigh ; 1 edwards way; irvine, CA 92614 ; 9492503939
• MDR Report Key: 13712905
• MDR Text Key: 286881669
• Report Number: 2015691-2022-04336
• 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: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/01/2022

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 Expiration Date: 03/29/2023
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• 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: 02/16/2022
• Initial Date FDA Received: 03/09/2022
• Supplement Dates Manufacturer Received: 03/23/2022
• Supplement Dates FDA Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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