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

Model Number	A09-009
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula extension set (lot no.00159671) was used on the patient from (b)(6) 2025- until the extension set was exchanged on (b)(6) 2026.The event occurred on 2026-02-17, which is (60 days) after the extension set was placed on the patient being supported with an excor active driving unit.We have reviewed the device history record (dhr) of the extension set lot no.00159671.This product was produced according to our specifications.According to the production records, a total of 6 extension sets with this lot no.Were produced.All the six sets with this lot no.Were distributed in the usa.Among them, two sets were used on two patients.There are no other complaints associated with this lot number.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
The site contacted berlin heart inc.Clinical affairs on (b)(6) 2026 to report an "external scratch" observed on excor cannula extension set ø 9/9 mm parallel to the titanium connector of the rvad inflow cannula.The site reported the scratch to be a new finding as it was not present the previous day.The site also reported that the silicone feels separated despite the tube being intact.The site is unaware how this scratch occurred.On the same day, the patient underwent a blood pump and an extension set exchange without incident.The patient remained hemodynamically stable throughout the procedure and the excor blood pump continued to function as intended, maintaining full fill and ejection throughout.At the time of the event, all the cannula and connector lengths, as well as the distance between titanium connectors, were symmetrical and within the recommendations outlined in the ifu.Excor cable ties were positioned per ifu.No prior damage or modifications to the cannulas or connector sets were noted.
Additional Manufacturer Narrative
The event occurred on 2026-02-17, which is 60 days after the connecting set in question was placed on the patient.On the same day of the event, the connecting set was exchanged and sent to berlin heart for investigation.Based on the picture provided by the clinic at the time of the event, the reported "external scratch on the connector tube" was observed, confirming the reported anomaly.During examination of the tube section at berlin heart, the external damage was confirmed.The type and location of the external damage (scratch) indicates that this point on the cannula must have come into contact with a relatively hard or sharp object from the patient's environment.The damage was noticed by the clinic staff and the 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: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 24502980
• Report Number: 3004582654-2026-00014
• Device Sequence Number: 16066418
• Product Code: DSQ
• UDI-Device Identifier: 04260090040171
• UDI-Public: (01)04260090040171(17)280815(10)00159671
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2026

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: A09-009
• Device Lot Number: 00159671
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2025
• 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: 6 YR
• Patient Sex: Female
• Patient Weight: 17 KG