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

Model Number	C23V-004M
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/13/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2025-11-05 the site contacted berlin heart inc.Clinical affairs (ca) to report that a pump change occurred on (b)(6) 2025 due to concern regarding the distal end of the inflow excor atrial cannula for children ø 12/9 mm, which appeared "stressed" and budded under the cable tie.According to the site contact, the affected portion of the cannula was cut and discarded, and a new excor cannula extension set ø 9/9 mm and blood pump were successfully placed without any adverse events.When questioned about the cable tie gun setting, the site confirmed that no adjustments were made and that it remains on the original, recommended setting.Prior to the exchange, the blood pump demonstrated complete filling and ejection, and the patient remained hemodynamically stable throughout.Although this event had no negative effect on the patient, this kind of defect could potentially result in a disruption of the cannula.Therefore, berlin heart decided to report this event due to concerns about the possible risk.
Additional Manufacturer Narrative
The event occurred on 2025-04-13, which is (36 days) after the excor atrial cannula (lot 00124424) was placed on the patient on (b)(6) 2025.The cannula continued to remain for further 141 days on the patient until the patient was transplanted on (b)(6) 2025.The patient was being supported with an excor active driver.The affected cannula was not returned to berlin heart for investigation, as the affected section of the cannula in question was already discarded.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.00124424.This product was produced according to our specifications.According to the production record, a total of 4 cannulae with this lot no.Were produced.Out of the four cannulas, three were cannulas distributed in the us were used on patients.The fourth cannula was distributed to spain.All patients were successfully transplanted.There are no more complaints associated with this lot number except the current complaint.

• 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: 23632763
• Report Number: 3004582654-2025-00064
• Device Sequence Number: 9290698
• Product Code: DSQ
• UDI-Device Identifier: 04260090041291
• UDI-Public: (01)04260090041291(17)250831(10)00124424
• 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 Expiration Date: 08/31/2025
• Device Model Number: C23V-004M
• Device Lot Number: 00124424
• 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: 10/25/2022
• 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: 17 MO
• Patient Sex: Male
• Patient Weight: 10 KG