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

Model Number	C22A-004
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 2025-02-24, the site contacted berlin heart inc.Clinical affairs (ca) to report an issue with the excor apex cannula for children ø 12/9 mm; l 27 cm (lot 00146674).The site observed a crack at the pump-cannula connection.Upon evaluating the pictures provided by the site, ca confirmed the presence of the crack and advised the site to replace the affected part of the cannula immediately.The site performed a pump change on (b)(6)2025.The affected part of the cannula was also cut from the cannula and sent to berlin heart along with the pump.During the event, the pump maintained complete filling and ejection, and no leakage from the cannula was noted.The patient remained hemodynamically stable throughout the event.
Additional Manufacturer Narrative
The excor apex cannula for children ø 12/9 mm; l 27 cm (lot 00146674) was in use on the patient from (b)(6) 2025 to date.The event occurred on 2025-02-24, which is (32 days) after the cannula was placed on the patient.We have reviewed the production records of the connecting set lot no.00146674.This product was produced according to our specification.According to the production record, a total of five cannulas with this lot no.Were produced.All the cannulas were distributed in the usa.Three out of the five cannulas are implanted on patients, and two remain in stock.There are no other complaints associated with this lot number.A detailed investigation report will be provided as soon as it is available.
Additional Manufacturer Narrative
The affected cannula section along with the blood pump was returned to berlin heart gmbh.The reported event occurred on 2025-02-24, which is (32 days) after the cannula in question was placed on the patient.During initial visual inspection of the returned section of the cannula, the crack reported was confirmed.The imprints observed around the cracked area of the cannula indicate that the affected area was squeezed with forceps or a clamp, resulting in the crack.The imprint pattern on the cannula surface was observed on the opposite sides (180 degrees apart).The damage was noticed by a clinic staff and appropriate action was taken.

• 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 21657644
• Report Number: 3004582654-2025-00017
• Device Sequence Number: 7547433
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: (01)04260090040492(17)270813(10)00146674
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 04/24/2025

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: C22A-004
• Device Lot Number: 00146674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 04/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2024
• 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: 9 MO
• Patient Sex: Female
• Patient Weight: 8 KG