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	03/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula extension set (lot no.00143834) was used on the patient from (b)(6) 2025 to date.The event occurred on (b)(6) 2026, which is (207 days) after the extension set was placed on the patient, who is being supported with an excor active driving unit.We have reviewed the device history record (dhr) of the extension set lot no.00143834.This product was produced according to our specifications.According to the production records, a total of three extension sets with this lot no.Were produced.Out of three extension sets, two were distributed in the usa and used on patients.The last one was distributed in the uk.There are no other complaints associated with this lot number.
Event or Problem Description
The site contacted berlin heart inc.Clinical affairs via phone on (b)(6) 2026 and provided a photo to inquire about a circumferential internal scratch observed above the titanium connector on excor cannula extension set ø 9/9 mm.The site reported that the cannula length had not been shortened since removal from the packaging.The titanium connectors were noted to have the appropriate distance between them and were the same length as the outflow cannula connector, appearing symmetrical.Berlin-provided cable ties were applied per the ifu, and no previous damage had been observed.The site reported that the scratch was newly observed.At the time of the report, the patient remained hemodynamically stable and the excor blood pump continued to function as intended, maintaining full fill and ejection throughout.The site contacted bhi ca to report that the surgeon will continue monitoring the affected area of the cannula extension, despite bhi ca's recommendation to proceed with an exchange.Bhi ca educated the site contact on the importance of close monitoring of the affected cannula extension and recommended placement of perfusion tubing over the cannula extension to provide additional support and create a wider protective barrier.

• 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: mary beth tate ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 7347092080
• MDR Report Key: 24866517
• Report Number: 3004582654-2026-00022
• Device Sequence Number: 18485876
• Product Code: DSQ
• UDI-Device Identifier: 04260090040171
• UDI-Public: (01)04260090040171(17)270518(10)00143834
• 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): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial
• 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: 00143834
• 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: 03/16/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/13/2024
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 9 KG