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	12/05/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cannula (lot no.00102986) was in use on the patient until the time of the event on 2023-12-05 (470 days).We have reviewed the production records of the excor aterial cannula lot no.00102986.This product was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
Berlin heart was informed by the clinic on 2023-12-05 that a cannula breach on a patient supported in bvad configuration.The breach occurred on (the lvad), the left outflow cannula above the cable tie.The breached cannula were clamped and left berlin heart blood pump (lvad) was disconnected.The patient received cpr and was transferred to icu and connected to ecmo on the left side.The right side was still supported with the berlin heart blood pump.The patient is still sedated and under strict observation.Ct scan showed no brain injury.Lung of the patient is not working appropriate since the event.Note: during a routine inspection, a defect on the outer surface of the same cannula was found earlier on 2023-09-07.However, no breach occurred.In this case, the cannula was shortened as a precautionary measure.
Additional Manufacturer Narrative
The documentation of the production (dhr - device history record) of the cannula c80g-021mx01 (lot no.00102986) was reviewed during the failure investigation.The review of our product documentation confirmed that all manufacturing and testing process steps were performed correctly and according to specifications.No deviations were found.The berlin heart performed only a non- destructive visual inspection with microscopic images and several high-resolution ct scans.Ct scans were performed by an external laboratory under the observation of the manufacturer.Ct scans were performed with a resolution of approximately 15 micro meter as a 360° full scan.This allowed a partitioning of the 3d geometry over all axes for the investigation.For findings & conclusion see attached failure investigation report.
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: 18325579
• Report Number: 3004582654-2023-00040
• Device Sequence Number: 7358512
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352,(17)231231,(10)00102986
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup,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: 12/31/2023
• Device Model Number: C80G-021M
• Device Catalogue Number: C80G-021M
• Device Lot Number: 00102986
• 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: 12/05/2023
• Supplement Date Received by Manufacturer: 12/05/2023; Not provided
• Initial Report FDA Received Date: 12/14/2023
• Supplement Report FDA Received Date: 02/20/2024; 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2021
• 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: 4 KG