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 Insufficient Information (3190)

Patient Problem Foreign Body In Patient (2687)

Event Type  Injury  

Manufacturer Narrative

The device was not returned for evaluation; it was discarded at the hospital.Without 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.Lot number was not provided; therefore review of the manufacturing records could not be completed.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.

Event Description

It was reported that unknown material was detected inside the patient body by ct scanning after the patient was discharged from the hospital.The catheter was inserted to the patient around (b)(6) 2021.At the end of (b)(6), contrast enhanced ct was performed with electrocardiogram, and the unknown material was found to be approximately 1.5 cm size, tubing shaped-like material.The tubing shaped-like material was located and stuck at closer to the right atrium of the superior vena cava.When the catheter was removed, the customer confirmed that there was clotted blood on the catheter, but they did not verify any shape abnormalities on the catheter.The customer reported the event since there is a possibility that the unknown material could be the catheter, however there is no definitive evidence that supports the unknown material is the catheter.The event will continue to be examined at the facility.Information such as if there were any abnormalities observed on the catheter before use and during the catheter removal, and when the patient was discharged from the hospital is unknown.What kind of surgery/examination the catheter was used for, if operative note and ct image can be obtained are currently followed-up by the sales rep.Patient demographic information requested but unavailable.The device was discarded by the hospital.(b)(6) 2021 the catheter referred in this complaint is a swan ganz catheter (777f8).

Manufacturer Narrative

Additional information was received that the patient was admitted to the hospital due to cardiogenic shock.The catheter was inserted and placed to the patient under radiographic guidance.There were no issues observed when measuring the pulmonary artery wedge pressure (pawp).The catheter was inserted to perform right heart catheter examination for cardiogenic shock and placed in the patient body for 11 days as a treatment indicator.On the 9th day of use, issues with waveform were observed when measuring the pulmonary artery pressure (pap).Per the ifu, the incidence of complications increases significantly with indwelling periods longer than 72 hours (the problem was not solved by adjusting the catheter position, but the exact detail is unknown.The problem was not solved by adjusting the catheter position, but the exact detail is unknown.There was no resistance felt when removing the catheter.Clotted blood was observed on the catheter body after the catheter removal.The customer did not perform a thorough examination of the catheter but there were no visible abnormalities observed on the catheter before use.The patient originally had phthisis and underwent an operation for appendicitis.The severity is not serious, but the patients outcome is not recovered.The causality between the device and the event was reported as remote.The tubing shaped-like material was not shrunk or resolved with anticoagulation treatment, so possibility of blood clot was low.Implantation of an implantable cardioverter-defibrillator (icd) was considered, but the location of the tubing shaped-like material would have interfered the icd lead, so the implantation of icd was not performed.Around the same time when the swan ganz catheter was inserted and placed in the patient, a temporary pacemaker (inserted from the right femoral vein) and a vascular access (quad-lumen, inserted from the left femoral vein) were placed in the vein for a long period, but no visible separation was observed when removing both devices.In addition, both devices were inserted from the femoral vein, and did not pass through the svc, which leads to the possibility of retained device other than swan ganz catheter was low.The swan ganz catheter was the only device that passed through the same svc at that time.The tubing shaped-like material is not visible with radiographic guidance, and open chest surgery will be required to remove the material, so the patient will be monitored through follow-ups.Operative note or detail of the right heart catheter examination was not available.A ct scan was not available since the patient did not permit.Patients demographics were received.A review of the manufacturing records indicated that the product met specifications upon release.It is not known if some procedural factors may have contributed to the event.There was no evidence of a manufacturing nonconformance.

• 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 PR 00610
• MDR Report Key: 12289836
• MDR Text Key: 265591540
• Report Number: 2015691-2021-04533
• Device Sequence Number: 1
• Product Code: DQE
• Combination Product (y/n): N
• PMA/PMN Number: K040287
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 09/16/2021

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/02/2022
• Device Model Number: 777F8
• Device Catalogue Number: 777F8
• Device Lot Number: 63076709
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/14/2021
• Initial Date FDA Received: 08/06/2021
• Supplement Dates Manufacturer Received: 09/02/2021
• Supplement Dates FDA Received: 09/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 67 YR
• Patient Weight: 36