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

Model Number	L20H-002X01
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor driving tube, lot no.00152640, was in use on the patient from 2025-08-12 until the driving tube was exchanged on 2026-02-09.The event occurred on 2026-02-09, which is (181 days) after the driving tube was placed on the patient.The patient was being supported with an excor active when the affected driving tube was placed.There were several driver exchanges between excor ikus and excor active during this time until the event occurred.The patient is being supported on active driver as of on (b)(6) 2026.We have reviewed the device history record (dhr) of the driving tube lot no.00152640.This product was produced according to our specifications.There are no other complaints associated with either lot number.The affected driving tube was returned to berlin heart for investigation on 2026-02-19.During the initial visual inspection of the returned driving tube, the crack in the driving tube described was confirmed.The crack was located directly at the pump connection.The fracture surface is uneven and rough.A fracture pattern can be seen, starting from the point of maximum deflection.The fracture surface runs perpendicular to the component axis.The crack is located at the end of the driving tube.The overall appearance of the damage indicates high bending stress, which occurred directly at the pump connection.The course of a bending fracture is characterized by failure on the tension side, which continues towards the compression side.The damage was most likely caused by the patient's activity.
Event or Problem Description
On 2026-02-09, berlin heart clinical affairs was informed by the japanese distributor that the clinic noted a crack in the excor driving tube l20h-002x01 and the driving tube was exchanged without any complications.The excor blood pump maintained complete filling and ejection throughout.The patient had no harm and no change in clinical status.

• 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: 24502220
• Report Number: 3004582654-2026-00013
• Device Sequence Number: 18745791
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: (01)04260090040560(17)280224(10)00152640
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 03/03/2026

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: L20H-002X01
• Device Lot Number: 00152640
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/19/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2026
• Initial Report FDA Received Date: 03/03/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/13/2025
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 12 KG