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

Model Number	A09-009
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula extension set (lot 00156114) was in use on the patient from (b)(6) 2025 to the cannula was replaced on (b)(6) 2025.The event occurred on 2025-10-01, which is (13 days) after the extension set was placed on the patient.The clinic provided berlin heart with three photos of the cannula extension set in question at the time of and after the event.The observation described can be confirmed based on the images from the clinic.The affected cannula extension set was not returned to berlin heart for investigation and was discarded by the clinic.Therefore, neither the failure nor the cause of the failure in question could be determined.We have reviewed the device history record (dhr) of the extension set lot no.00156114.This product was produced according to our specifications.According to the production record, a total of 3 extension sets with this lot no.Were produced.All extension sets were implanted in the patients in the usa.There are no more complaints associated with this lot number except the current complaint.
Event or Problem Description
The clinic contacted berlin heart inc.(bhi) clinical affairs (ca) on 2025-10-01 to report a concern for a internal "scratch or defect" in the excor cannula extension set on the rvad inflow side on a patient with excor bi-vad configuration.According to the clinic, they were unsure if it was a defect or a shadow but were concerned for the possibility of a defect due to the activity of the child.Bhi ca reviewed the image and recommended a pump change along with the change of the segment of the extension set.Bhi ca also recommended that the segment of the extension set in question be returned for further evaluation.The excor blood pump maintained complete filling and ejection throughout.On 2025-10-02, the clinic notified that an extension set change had occurred.According to the clinic, the segment of the extension in question was disposed of.The patient tolerated the extension set change with no untoward effects.

• 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: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 23394517
• Report Number: 3004582654-2025-00058
• Device Sequence Number: 10052757
• Product Code: DSQ
• UDI-Device Identifier: 04260090040171
• UDI-Public: (01)04260090040171(17)280518(10)00156114
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/27/2025

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 Model Number: A09-009
• Device Lot Number: 00156114
• 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: 10/01/2025
• Initial Report FDA Received Date: 10/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/11/2025
• 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: 10 YR
• Patient Sex: Male
• Patient Weight: 20 KG