MAUDE Adverse Event Report: CLEARFLOW, INC. PFFG-24; CATHETER

Model Number	PFFG-24
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Codes	Bradycardia (1751); Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	05/16/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Between 2% and 8% of all patients have to go back for post op for bleeding after cardiac surgery.(this is quoted in the loor paper with references).Side branch bleeding is one of the most common sources of bleeding when a patient is taken back.Clearflow device is intended to remove clots formed inside the chest tube.
Event or Problem Description
A day after cabgx2 procedure, the patient was taken back to repair a torn vein graft.The customer reported that a clip on the patient's graft may have been attached to the blood clot removed.The pffg was placed in anterior mediastinum.There is no information available if there was a clip used at the site, according to the customer.No clip was found in the cf device or drainage canister according to the hospital.There was no serious injury.The patient's graft was sutured and another pffg was used.The patient has recovered.

• Brand Name: PFFG-24
• Common Device Name: CATHETER
• Manufacturer (Section D): CLEARFLOW, INC.; 140 technology dr; suite 100; irvine,
• MDR Report Key: 10171460
• Report Number: 3008782989-2020-00001
• Device Sequence Number: 2142882
• Product Code: OTK
• UDI-Device Identifier: 20856449006066
• UDI-Public: 012085644900606617220820101011105
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: 163139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/18/2020

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 Expiration Date: 08/20/2022
• Device Model Number: PFFG-24
• Device Catalogue Number: PFFG-24
• Device Lot Number: 1011105
• Was Device Available for Evaluation?: No
• Device Age: 4 MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2020
• Initial Report FDA Received Date: 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 106