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

Model Number	C23V-004M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, the site reported that a kink was observed in the inflow cannula of a patient.It had been present for a few days without being reported to the berlin heart inc.Clinical affairs (ca) team.Ca requested pictures to assess the kink.Upon reviewing the pictures, ca recommended trimming off the inflow cannula with the confirmed kink.Additionally, at the time of the event the blood pump maintained complete fill and ejection, no cannula breach and the patient remained hemodynamically stable.Therefore, it was decided this incident was not reportable.However, after completing the failure investigation on 2023-10-12, it was determined that it was not a kink, it was a cut outside the cannula.Therefore, it was determined this was reportable as mdr.
Additional Manufacturer Narrative
We have reviewed the production records of the excor aterial cannula lot no.00110486.This product was produced according to our specifications.The affected cannula had been in use on the patient for 64 days up to the time of the incident.The trimmed section of the cannula was returned to berlin heart gmbh on 2023-08-30.The subsequent microscopic examination determined that it was not a kink but damage to the outer surface.The damage is approximately 1 to 2 mm long.It is palpable and looks like an incision.Based on all examinations, it was concluded that it was external damage, most likely caused by a sharp and pointed object.See attached failure investigation report for details.
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, deu 12247 ; GM 12247
• Manufacturer (Section G): BERLIN HEART GMBH; wiesenweg 10; berlin, deu 12247 ; GM 12247
• Manufacturer Contact: dudley rajapaksa ; 9391 grogans mill road; suite a6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 17953684
• Report Number: 3004582654-2023-00031
• Device Sequence Number: 6800036
• Product Code: DSQ
• UDI-Device Identifier: 04260090041291
• UDI-Public: (01)04260090041291,(17)240630,(10)00110486
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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): 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: 06/30/2024
• Device Model Number: C23V-004M
• Device Catalogue Number: C23V-004M
• Device Lot Number: 00110486
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2023
• Supplement Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2021
• 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: 24 MO
• Patient Sex: Male
• Patient Weight: 12 KG