MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN; VENTRICULAR ASSIST DEVICE

Model Number	C80G-021M
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	09/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Berlin heart gmbh clinical affairs was informed by the clinic that a patient had an ischemic stroke on (b)(6) 2023.The cannula washout was done and the connector set was exchanged due to fibrin deposits at the same day.Ct scan result showed acute and subacute r) infarctions, some residual lll weakness.After reviewing the information related to this ae, it was decided to report on 01/29/2024.
Additional Manufacturer Narrative
The cannula (lot no.00102986) was in use on the patient from (b)(6) 2022 until the time of the event on 2023-09-22 (396 days).We have reviewed the production records of the excor aterial cannula lot no.00102986.This product was produced according to our specification.

• Brand Name: EXCOR ARTERIAL CANNULA FOR SMALL CHILDREN
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 18695936
• Report Number: 3004582654-2024-00010
• Device Sequence Number: 8357964
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: 04260090041352
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P160035
• 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,User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/13/2024

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: 12/31/2023
• Device Model Number: C80G-021M
• Device Catalogue Number: C80G-021M
• 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: 10/04/2023
• Initial Report FDA Received Date: 02/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/27/2021
• 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: Other
• Patient Age: 14 MO
• Patient Sex: Male
• Patient Weight: 5 KG