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

Model Number	C80G-021M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Berlin heart clinical affairs was informed by the clinic on (b)(6) 2023 that a small crack on the outflow cannula was detected.The surgeon cut off the damaged cannula end and connected the new pump for safety reason.The patient was clinically stable and had no negative effects due to the incident.No picture of the cannula in question was taken and the cannula end trimmed was discarded by the clinic.
Additional Manufacturer Narrative
The cannula (lot no.00125836) was in use on the patient from (b)(6) 2023 until the time of the event on 2023-12-08 (154 days).We have reviewed the production records of the excor aterial cannula lot no.00125836.This product was produced according to our specification.A total of 5 cannulas with the lot no.00125836 were manufactured and distributed to 4 different countries.It has so far been confirmed that 4 of them were used on patients and one patient was transplanted and 3 patients are still on the berlin heart system, including the patient subjected to this incident.There is no other complaints related any cannula from this lot.
Additional Manufacturer Narrative
Data corrected in section d to match device information in gudid per the fda letter dated 5/20/2024.D1 changed the brand name to match gudid.D2a changed the common device name to match gudid.D4 udi changed, to include complete udi number (b)(4).

• 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: 18368334
• Report Number: 3004582654-2023-00041
• Device Sequence Number: 7710666
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352,(17)250930,(10)00125836
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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: 09/30/2025
• Device Model Number: C80G-021M
• Device Catalogue Number: C80G-021M
• Device Lot Number: 00125836
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/20/2023
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/15/2022
• 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: 6 KG