MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR®; VENTRICULAR (ASSIST) BYPASS

Model Number	C60G-004M
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/04/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The arterial cannula for children ø 12/9 mm; l 32 cm (lot no.00123550) was in use on the patient from (b)(6) 2024 to date.The event occurred on 2024-12-04, which is (112 days) after the cannula was placed on the patient.The excor® ikus stationary driving unit sn (b)(6) is used on this patient.We have reviewed the production records of the cannula lot no.00123550.This product was produced according to our specifications.According to the production records, a total of 5 cannulas were produced in this lot.All of them were distributed in the usa.3 out of 5 cannulas are implanted on the patients, and 2 remain in stock.There are no complaints associated with this lot except the current complaint associated with this patient.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On (b)(6) 2024 the site contacted berlin heart inc.Clinical affairs (ca) to report a scratch on the outflow cannula at the cannula-pump junction with blood surrounding the metal connector of the pump.Ca requested pictures of the reported concern.Upon reviewing the pictures, ca confirmed the scratch and the blood around the connection of the pump.Ca recommended that the site remove the affected section of cannula and replace the blood pump if needed.Despite the issue, the excor blood pump maintained complete filling and ejection, the patient remained stable, and no significant clinical complications were reported.On (b)(6) 2024, the affected section of the cannula was trimmed, and the pump was exchanged due to the reported issue.
Additional Manufacturer Narrative
On 2024-12-13, the excor arterial cannula for children, lot no: 00123550 was returned to berlin heart gmbh for investigation.The affected cannula section was returned along with the blood pump, which was placed 2 days after the implantation of the cannula in question.During the initial visual inspection of the returned cannula section, the reported scratch was confirmed.The scratch was superficial and did not extend into the depth of the cannula tube.However, the blood surrounding the metal connector of the pump could not be verified.The type and location of the reported external scratch indicates that this area of the cannula must have been in contact with a sharp-edged object around the patient.The scratch was noticed by a clinical staff and appropriate actions were taken.The blood surrounding the metal connector of the pump could only be confirmed based on the picture provided by the clinic.However, no defect or disturbance of the surface in the blood-carrying area of the tube section could be detected.It is likely that some blood entered between the cannula and the connector at this location due to possible factors such as patient's mobility or positioning / fixation of the blood pump or dressing changes that may have deformed the cannula.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 21056769
• Report Number: 3004582654-2025-00001
• Device Sequence Number: 18306934
• Product Code: DSQ
• UDI-Device Identifier: 04260090041338
• UDI-Public: (01)04260090041338(17)250630(10)00123550
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2025
• Device Model Number: C60G-004M
• Device Lot Number: 00123550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/14/2022
• 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
• Patient Age: 3 YR
• Patient Sex: Male
• Patient Weight: 14 KG