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

Model Number	C80G-021M
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor arterial cannula for small children ø 6 mm; l 25 cm (lot 00131429) was in use on the patient from (b)(6) 2024 to date.The event occurred on 2025-07-17, which is (526 days) after the cannula was placed on the patient.We have reviewed the production records of the connecting set lot no.00131429 and concluded this product was produced according to our specification.According to the production records, a total of five cannulas with this lot no.Were produced.Three of them were distributed and used on patients in the usa.Two patients among them were successfully transplanted and one patient was weaned.A total of two cannulas were distributed in japan.One cannula was used on the patient associated with the current complaint, and the second cannula was returned to the manufacturer by the site in sterile condition.There are no more complaints associated with this lot number.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On 2025-07-17, berlin heart gmbh clinical affairs (ca) was informed by the japanese distributor that the clinic found a small drop of blood leakage and consequently found damage to the excor arterial cannula for small children ø 6 mm; l 25 cm.A small crack was noted on the outflow cannula between the end of the titanium connector and the cable tie.Due to this issue, the pump was replaced and the affected section of the cannula was trimmed.The patient was very active, and the connection between the pump and the cannula was bent frequently.The outflow cannula was slightly longer than the inflow cannula.Throughout the event the patient remained hemodynamically stable with no significant clinical complications.
Additional Manufacturer Narrative
The event occurred on (b)(6) 2025, which is 526 days after the cannula in question was placed on the patient.The affected cannula section was returned to berlin heart for investigation.During the external visual inspection of the returned products, a crack was found at the inflow end of the cannula.The crack is located between the connector edge and the cable tie.It is approximately 2 to 3 mm long in circumference.There are further marks and scratches on the cannula section.The overall picture of the damage indicates high mechanical stress directly at the pump connection.The damage was most likely initiated by a hard object that eventually worsened by the patient's activity, leading to a leak.According to the clinic, the patient was very active and the connection between the pump and the cannula was bent very often.It is suspected that the rupture was caused by a scratch that occurred when connecting the pump.

• 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: 22676227
• Report Number: 3004582654-2025-00044
• Device Sequence Number: 9565987
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352(17)260430(10)00131429
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• 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 Expiration Date: 04/30/2026
• Device Model Number: C80G-021M
• Device Lot Number: 00131429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 09/19/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2023
• 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: 7 YR
• Patient Sex: Female
• Patient Weight: 12 KG