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	06/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor driving tube, lot 00146903, was in use on the patient for 57 days from (b)(6) 2025 until the driving tube was exchanged on (b)(6) 2025.The patient was successfully transplanted on (b)(6) 2025.The manufacturer has reviewed the production records of the excor driving tube, lot 00146903 and concluded that the product was produced according to their specifications.The excor® active driving unit was used on this patient.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On (b)(6) 2025 the clinic contacted berlin heart inc.Clinical affairs to report that the excor driving tube l20h-002x01 was changed due to an audible and palpable air leak.According to the site, the air leak was noted in the driving tube around the area where it connected to the blood pump.The cable tie was noted to be secure and in the proper positioning.A review of log files revealed several h1: pressure loss alarms on the excor active driving unit at the time of event.These alarms were muted by the user.The excor blood pump maintained complete filling and ejection throughout.The affected driving tube was changed, and the patient tolerated the driving tube change with no significant clinical complications.
Additional Manufacturer Narrative
The excor driving tube, red; ø 6/8 mm l 2 m, lot 00146903, was in use on the patient from (b)(6) 2025 until it was replaced on (b)(6) 2025 for 57 days.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.In addition, further superficial damage was detected immediately adjacent to the crack.The crack is located at the end of the drive tube.The overall appearance of the damage indicates wear and high bending stress directly at the pump connection.The damage was most likely caused by a hard object and eventually worsened by the patient's activity, resulting in a leak.

• 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: 22385313
• Report Number: 3004582654-2025-00037
• Device Sequence Number: 7138249
• Product Code: DSQ
• UDI-Device Identifier: 04260090040560
• UDI-Public: (01)04260090040560(17)271002(10)00146903
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2025

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: L20H-002X01
• Device Lot Number: 00146903
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/29/2024
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 18 KG