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	11/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor atrial cannula (lot 00142239) was implanted on the patient (b)(6) 2025 and remains on the patient to date.The event occurred on (b)(6) 2025, which is (219 days) after the cannula was placed on the patient being supported with an excor active driving unit.The affected cannula section is not returned to berlin heart for investigation, as the affected cannula section in question 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.00142239.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 is one complaint associated with this lot number that occurred on the same patient.This event has been submitted as 3004582654-2025-00065.
Event or Problem Description
On (b)(6) 2025, the site contacted berlin heart inc.(bhi) clinical affairs (ca) to report that a portion of the excor atrial cannula for small children ø 6 mm; l 25 cm in rvad had been excised due to an external scratch on the cannula, 4-5 mm below the velour.According to the site, the concerning portion of the cannula was excised and a new excor extension set; ø 6/6 mm was placed.Due to the location of the defect, the titanium stub of the extension set is under the velour.The site reported that the excision and extension placement went without incident and the patient remained hemodynamically stable throughout.The excor blood pump functioned as intended, maintaining complete filling and ejection throughout.The site reported that the excised portion of the cannula was discarded and therefore will not be returned to bhi for further evaluation.

• 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: 23715959
• Report Number: 3004582654-2025-00068
• Device Sequence Number: 10260089
• Product Code: DSQ
• UDI-Device Identifier: 04260090041277
• UDI-Public: (01)04260090041277(17)270228(10)00142239
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 12/04/2025

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: C19V-020M
• Device Lot Number: 00142239
• 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: 11/15/2025
• Initial Report FDA Received Date: 12/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2024
• 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: 13 MO
• Patient Sex: Male
• Patient Weight: 8 KG