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

Model Number	C18A-020
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The apex cannula (lot 00148871) was implanted on the patient on (b)(6) 2025 and remains on the patient to date.The event occurred on (b)(6) 2025, which is (253 days) after the cannula was placed on the patient being supported with an excor ikus driving unit.The affected cannula section is not returned to berlin heart for investigation, as it 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.00148871.This product was produced according to our specifications.According to the production record, a total of 5 cannulas with this lot no.Were produced.Out of the five cannulas with this lot no., two were distributed in the usa and one cannula was distributed in czech republic.All patients implanted with the cannulas were successfully transplanted.Two cannulas were distributed in canada and one patient was weaned for recovery.There are no other complaints associated with either lot number.
Event or Problem Description
The site notified berlin heart inc.(bhi) clinical affairs (ca) via email on 2025-12-01 that a excor apex cannula disruption occurred on (b)(6) 2025.Bhi ca called the site to get additional information.The site reported that during a routine pump assessment, the rn lifted the pump, twisting it slightly to assess the membrane movement.When the rn lifted the pump, a spray of blood came from the inflow cannula.The cannulas were immediately clamped, and blood was noted on the exterior side of inflow cannula.No air was noted in the pump.The blood pump was disconnected, and the cannulas were examined by the surgeon.No area of compromise was visible on the inflow cannula, and both cannulas were trimmed out of an abundance of caution.The blood pump was reconnected without incident.The patient remained hemodynamically stable throughout, and all assessments are within normal limits (wnl).At the time of the report, the trimmed portion of the cannulas had been discarded and could not be returned.The site also reported that all zip ties were securely in place at the time of the event, and that all cannula lengths were within the recommended specifications.

• 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 INC; 9391 grogan's mill road; suite a-6; the woodlands TX 77380
• Manufacturer Contact: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 23849905
• Report Number: 3004582654-2025-00071
• Device Sequence Number: 13251326
• Product Code: DSQ
• UDI-Device Identifier: 04260090040515
• UDI-Public: (01)04260090040515(17)271023(10)00148871
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 12/19/2025

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: C18A-020
• Device Lot Number: 00148871
• 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: 12/01/2025
• Initial Report FDA Received Date: 12/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/08/2024
• 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: 5 MO
• Patient Sex: Male
• Patient Weight: 7 KG