MAUDE Adverse Event Report: PERFUSION SYSTEMS ARTERIAL CANNULA; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	71424
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that during use of a dlp flexible arch arterial cannula, it was reported that the cuff on the cannula was loose.  the cuff from the cannula fell into the patient's chest cavity, the cuff was retrieved and there were no further complications.The device was replaced to complete the procedure.There was no patient impact associated with this event.Medtronic received additional information that the cuff was retrieved when the patient¿s chest was still open.It was visible in the chest cavity and the surgeon was able to easily retrieve it and the patient was not affected.Medtronic received additional information that forceps were used to remove the cuff.The customer stated that it was removed under direct vision.

• Brand Name: ARTERIAL CANNULA
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 15073257
• Report Number: 2184009-2022-00178
• Device Sequence Number: 17528140
• Product Code: DWF
• UDI-Device Identifier: 00643169084520
• UDI-Public: 00643169084520
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K840001
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/21/2022

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/03/2025
• Device Model Number: 71424
• Device Catalogue Number: 71424
• Device Lot Number: 2022030038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2022
• Initial Report FDA Received Date: 07/21/2022
• Date Device Manufactured: 03/03/2022
• 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 Sex: Unknown