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

Model Number	C19V-020M
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cannulas including the affected cannula (lot 00145706) were first implanted on the patient (b)(6) 2025, and the excor blood pump was placed on (b)(6) 2025.The event occurred on 2025-11-18, which is (286 days) after the cannula was placed on the patient and the affected cannula still remains on the patient being supported with an excor active driving unit.The affected section of the cannula was excised on (b)(6) 2025, and a 6-6 mm extension set was placed successfully.We have reviewed the device history record (dhr) of the cannula lot no.00145706.This product was produced according to our specifications.According to the production record, a total of 4 cannulas with this lot no.Were produced.All cannulas were distributed in the usa and used.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.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) on 2025-11-18 to report an external, palpable, scratch that was found on the excor atrial cannula for small children ø 6 mm; l 25 cm right below the velour.The site planned to excise the affected area and place a new excor extension set; ø 6/6 mm.According to the site the patient currently remained hemodynamically stable throughout, and the excor blood pump functioned as intended, maintaining complete filling and ejection.The patient had no harm due to the event.On 2025-11-20, which is (2 days) after the event, the site notified bhi ca that the affected portion of the cannula was excised, and a 6-6 extension set was placed successfully.
Additional Manufacturer Narrative
The event occurred on (b)(6) 2025, which is 286 days after the cannula in question was placed on the patient.On the same day of the event, the cannula was shortened and sent to berlin heart for examination.Based on the picture provided by the clinic at the time of the event, the reported internal scratches were observed, confirming the reported anomaly.However, the described scratch could not be found during the investigation with the returned cannula section.It is most likely that the scratched area was cut off from the affected cannula during the intervention of placing the extension set.Therefore, the cause of the reported scratch 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: 23715754
• Report Number: 3004582654-2025-00067
• Device Sequence Number: 8845479
• Product Code: DSQ
• UDI-Device Identifier: 04260090041277
• UDI-Public: (01)04260090041277(17)270725(10)00145706
• Combination Product (Y/N): N
• Initial Reporter State: UT
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2026

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: C19V-020M
• Device Lot Number: 00145706
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/04/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/29/2024
• 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: 17 MO
• Patient Sex: Male
• Patient Weight: 7 KG