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

Model Number	C19V-020M
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor atrial cannula (lot 00142239) was in use on the patient from (b)(6) 2025 to date.The event occurred on (b)(6) 2025, which is (157 days) after the cannula was placed on the patient.The patient is being supported with an excor active driver.The affected section of the cannula was not returned to berlin heart for investigation, as the affected section 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 cannula lot no.00142239.This product was produced according to our specifications.According to the production record, a total of 4 cannulae with this lot no.Were produced.All cannulae were distributed in the usa and were used.There are no more complaints associated with this lot number except the current complaint.
Event or Problem Description
On 2025-11-05 berlin heart inc.Clinical affairs (ca) was notified through the action database that on (b)(6) 2025, the inflow excor atrial cannula for small children ø 6 mm, on patient was trimmed due to fatigued tubing at the titanium connection.According to the site contact, the affected portion of the cannula was cut and discarded, and the blood pump was successfully re-connected without adverse effects to the patient.Prior to the exchange, the blood pump demonstrated complete filling and ejection, and the patient remained hemodynamically stable throughout the procedure.Although this event had no negative effect on the patient, this kind of defect could potentially result in a disruption the cannula.Therefore, berlin heart decided to report this event due to concerns about the possible risk.

• 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: 23632993
• Report Number: 3004582654-2025-00065
• Device Sequence Number: 9382047
• Product Code: DSQ
• UDI-Device Identifier: 04260090041277
• UDI-Public: (01)04260090041277(17)270228(10)00142239
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 11/24/2025

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: C19V-020M
• Device Lot Number: 00142239
• 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: 11/05/2025
• Initial Report FDA Received Date: 11/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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: 11 MO
• Patient Sex: Male
• Patient Weight: 7 KG