MAUDE Adverse Event Report: CLEARFLOW, INC. PLEURAFLOW SYSTEM WITH FLOWGLIDE; CHEST TUBE

Model Number	PFFG3-28
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	04/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The patient presented for surgery on april 20th and had a cabg x 2/avr.The surgeon placed two mediastinal chest tubes (1) pffg3-28 and (1) 24fr chest tube from another manufacturer (not identified).These two chest tubes were placed anteriorly in the mediastinum.A third chest tube, pffg3-28 ra, was placed in the left pleural space.Upon attempting the first actuation of the mediastinal chest tube (pffg3-28), the shuttle guide and clearance wire decoupled immediately.The decision was to close the sternum and leave it in this position and inform the cvicu team to not try and withdraw the shuttle and clearance wire per the ifu.Upon landing in the cvicu, the patient was bleeding heavily and after one (1) liter of drainage output in the first hour, the decision was made to return the patient to the or for re-exploration.The patient's chest was opened, and they discovered a dehiscence of the distal anastomosis of the lima-lad graft that was the cause for the bleeding.The surgeon re-anastomosed, achieved hemostasis, and closed the chest.It was reported by the surgeon that during the re-exploration the magnetic shuttle guide and clearance wire were not working (decoupling), so he removed it.Since the chest tube was not returned to the company and no photos were provided, the cause of decoupling could not be established.The returned clearance wire assembly was evaluated, and it was determined that it met applicable specifications.A review of manufacturing records indicated that the product was manufactured in accordance with specifications.It is not demonstrated that the device performance is associated with the performed re-exploration.The clearance wire assembly was returned to the company for investigation.Since only the clearance wire was returned to the company for investigation (the chest tube and remainder of the device were not returned), it is believed that the chest tube remained in place after re-exploration.Patient recovered thereafter and it was reported by nursing staff that based on the position of the chest tubes relative to the area of bleeding, the device had no cause/effect on the surgical bleeding issue.The surgeon performing re-exploration did not determine if the device contributed to the patient returning for bleeding.It was reported that the patient recovered normally after the medical intervention.
Additional Manufacturer Narrative
No root cause or device association is known at this time.

• Brand Name: PLEURAFLOW SYSTEM WITH FLOWGLIDE
• Common Device Name: CHEST TUBE
• Manufacturer (Section D): CLEARFLOW, INC.; 16 technology dr; suite 150; irvine 92618
• Manufacturer Contact: serrah namini ; 16 technology dr; suite 150; irvine 92618 ; 7149165010
• MDR Report Key: 16966906
• Report Number: 3008782989-2023-00001
• Device Sequence Number: 17490903
• Product Code: OTK
• UDI-Device Identifier: 00856449006192
• UDI-Public: 00856449006192
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K203394
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/18/2023

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
• Operator of Device: Health Professional
• Device Model Number: PFFG3-28
• Device Catalogue Number: PFFG3-28
• Device Lot Number: UNKN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2023
• Initial Report FDA Received Date: 05/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White