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

Model Number	C19V-020M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The atrial cannula for small children (lot no.00126464) was in use on the patient from (b)(6) 2023 until the time of the event on (b)(6) 2024 (477 days).We have reviewed the production records of the excor arterial cannula lot no.00126464.This product was produced according to our specification.According to the production records, a total of 5 cannulas with this lot no.Were produced.Out of 5 cannulas, 4 were distributed in usa and 1 was distributed in india.All the 4 cannulas were used on patients and 3 among them were explanted as all the 3 patients were successfully transplanted.This cannula complaint is associated with the 4th patient in the usa.There are no additional complaints associated with this lot number except the current complaint and another complaint from the same patient that occurred on (b)(6) 2024 which was submitted as 3004582654-2024-00059.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On 2024-11-12, the site contacted berlin heart inc.Clinical affairs (ca) to report a cut in the inflow atrial cannula for small children ø 6 mm; l 25 cm; head 14 mm (lot no.00126464) cannula of the rvad in a bvad configuration.The site noticed the cut during a routine pump assessment and deposit check.The site removed the defective part and replaced it with an extension set.Ca requested the return of the defective part for further investigation.During the event, both pumps maintained complete fill and ejection, and the patient was adequately supported.
Additional Manufacturer Narrative
On 2024-11-27, the excor cannula lot no.00126464 was returned to berlin heart gmbh for investigation.The clinic provided berlin heart with a photo of the cannula at the time of the event.Based on the image, the reported cut could be confirmed.However, the cut could not be confirmed during visual inspection of the returned cannula section.The damage to the cannula reported could not be found on the returned cannula section during examination.According to the new information received from the site, the damaged section of the cannula has been removed and is no longer on the patient.It is possible that the affected portion of the trimmed cannula section was inadvertently discarded by the clinic.

• 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: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 20792800
• Report Number: 3004582654-2024-00061
• Device Sequence Number: 6726607
• Product Code: DSQ
• UDI-Device Identifier: 04260090041277
• UDI-Public: (01)04260090041277(17)251031(10)00126464
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 01/09/2025

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: 10/31/2025
• Device Model Number: C19V-020M
• Device Lot Number: 00126464
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2024
• Supplement Report FDA Received Date: 01/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2022
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 11 KG