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

Model Number	C22A-004
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The site contacted berlin heart inc.On 2025-09-30 to report that on (b)(6) 2025 there had been an event involving a cannula breach with the patient identified in this report.According to the site, the patient was sitting up in a highchair when the nurse noticed a pinpoint sized drop of blood on the inflow excor apex cannula for children ø 12/9 mm; l 27 cm (lot 00143453), just above the titanium stub of the excor cannula extension set ø 9/9 mm (lot no.00149265).The rn clamped the cannula.The site further stated that the patient was taken to the operating room and successfully explanted from the excor system on the same day as the event.The patient remained hemodynamically stable throughout the event and has no reported neurological deficits.Of note, the patient was originally planned for explantation in that week due to recovery of heart function.
Additional Manufacturer Narrative
The excor apex cannula for children ø 12/9 mm; l 27 cm (lot 00143453) was in use on the patient from (b)(6) 2025 to the cannula was removed from the patient on (b)(6) 2025.The event occurred on 2025-09-29, which is (32 days) after the cannula was placed on the patient.We have reviewed the production records of the cannula lot no.00143543 and extension set lot no.00149265.Both the products were produced according to our specification.According to the production record, a total of 4 cannulas with this lot no.Were produced.Two cannulas were implanted in the patients in the usa, and both the patients were successfully transplanted.Two other cannulas were distributed in canada and both were successfully weaned for recovery.There are no more complaints associated with this lot number except the current complaint.A detailed investigation report will be provided as soon as it is available.
Additional Manufacturer Narrative
The excor apex cannula for children ø 12/9 mm; l 27 cm (lot 00143453) was returned to berlin heart, the manufacturer on 2025-10-24.Based on the picture provided by the clinic, the reported blood above the titanium stub of the 9-9 extension set, or a cannula breach could not be identified.During visual inspection of the returned cannula, the reported issue could not be verified initially due to debris on the returned cannula.After cleaning the cannula, no damage was found on the inflow cannula, directly above the titanium connector of the 9-9 extension set.A leak test was performed with the cannula for over five minutes at approximately 280 mmhg to identify any leaks.No pressure drop was observed during the test.No defect could be detected.The cannula in question met its specifications.The device history record (dhr) was reviewed, and no abnormalities were found.Therefore, the exact cause of the pinpoint sized droplet of blood at the cannula could not be determined.

• 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: 23358196
• Report Number: 3004582654-2025-00057
• Device Sequence Number: 8872071
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: (01)04260090040492(17)270506(10)00143453
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2025

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: C22A-004
• Device Lot Number: 00143453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/22/2025
• Supplement Report FDA Received Date: 12/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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: 12 MO
• Patient Sex: Female
• Patient Weight: 9 KG