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

Model Number	C80G-021M
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient was originally implanted with only cannulas including the affected arterial cannula (lot 00156523) on (b)(6) 2025.On the next day, the excor blood pump was placed on the patient.The event occurred on 2026-01-24, which is (99 days) after the cannula 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 cannula lot no.00156523.This product was produced according to our specifications.According to the production record, a total of 5 cannulas with this lot no.Were produced.All cannulas with this lot no.Were distributed in the usa and four of them were implanted.There are no other complaints associated with either 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.(bhi) clinical affairs (ca) via email on 2026-01-26 to report that on (b)(6) 2026 an excor arterial cannula for small children (lot 00156523) was frayed near the connection area of the excor blood pump.The bhi ca contacted the site to recommend that the damaged portion of the affected cannula be trimmed off.The site was informed to keep the removed portion of the cannula to return to berlin heart for further investigation.The berlin excor blood pump functioned as intended, maintaining complete filling and ejection throughout.On 2026-02-10, bhi ca followed up with the site about the patient, wherein the site informed berlin heart that the surgeon decided not to trim the affected secton of the cannula, and that they placed a second cable tie on the cannula to reinforce the area.As a result, bhi ca instructed the site to monitor the patient for any further complications, and that they return the affected portion of the cannula when it is trimmed, or the patient reaches an outcome.
Additional Manufacturer Narrative
The patient was originally implanted with only cannulas including the affected arterial cannula (lot 00156523) on (b)(6) 2025.On the next day, the excor blood pump was placed on the patient.The event occurred on (b)(6) 2026, which is (99 days) after the cannula 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 cannula lot no.00156523.This product was produced according to our specifications.According to the production record, a total of 5 cannulas with this lot no.Were produced.All cannulas with this lot no.Were distributed in the usa and four of them were implanted.There are no other complaints associated with either lot number.The affected cannula was not trimmed and remains on the patient.Therefore, the statement " a detailed investigation report will be provided as soon as it is available." from h10 has been deleted.

• 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: 24414610
• Report Number: 3004582654-2026-00010
• Device Sequence Number: 5916876
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352(17)280531(10)00156523
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2026

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: C80G-021M
• Device Lot Number: 00156523
• 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: 01/26/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 04/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/23/2025
• 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: 24 MO
• Patient Sex: Female
• Patient Weight: 8 KG