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

Model Number	L20H-002X01
Medical Device Problem Code	Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2025-05-30, the clinic contacted berlin heart gmbh affairs to report an incident with the excor driving tube l20h-002x01 on a patient supported with an excor active driving unit.The clinic stated that on (b)(6) 2025, the excor active emitted an h1 pressure loss alarm, and a crack in the driving tube was identified by the clinic personnel.The affected driving tube was replaced immediately without any problems.The patient remained stable throughout, and no negative effects were reported.The patient was successfully transplanted on (b)(6) 2025.
Additional Manufacturer Narrative
The excor driving tube, lot: 00130679, was in use on the patient for 556 days from on (b)(6) 2023 until the driving tube was exchanged on (b)(6) 2025.The manufacturer has reviewed the production records of the excor driving tube, lot: 00130679 and concluded that the product was produced according to their specifications.The excor® active driver was used on this patient.A detailed investigation report will be provided as soon as it is available.
Additional Manufacturer Narrative
The excor driving tube, red; ø 6/8 mm l 2 m, lot 00130679, was in use on the patient from (b)(6) 2023 until it was replaced on (b)(6) 2025 for 556 days.We have reviewed the production records of the excor driving tube, lot 00130679 and concluded this product was produced according to our specifications.During the initial visual inspection of the returned driving tube, the reported crack in the driving tube was confirmed.The crack was located directly at the pump connection at the end of the driving tube.Furthermore, various superficial damages were discovered in isolated cases along the driving tube.The overall appearance of the damage indicates wear and high bending stress that occurred directly at the pump connection.The damage was most likely caused by the patient's activity.The excor driving tube in question was used for 556 days until the defect occurred.According to our instructions for use (ifu) (chapter 4: product life), the excor driving tubes shall be used for 1 year only.In (b)(6) 2024, berlin heart sent a 330-day reminder to the clinic to inform them that the excor blood pump and connected driving tube of the affected patient have nearly reached their one year product lifetime.The clinic, however, told berlin heart on (b)(6) 2024, that they decided not to exchange both the components.

• 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: 22293799
• Report Number: 3004582654-2025-00031
• Device Sequence Number: 8893122
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: (01)04260090040560(17)260430(10)00130679
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 08/12/2025

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: 04/30/2026
• Device Model Number: L20H-002X01
• Device Lot Number: 00130679
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2023
• 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: 6 YR
• Patient Sex: Male
• Patient Weight: 10 KG