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

Model Number	C18A-020
Medical Device Problem Code	Scratched Material (3020)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) to report an external scratch that was noted in the excor apex cannula for small children.Of note, the site reported the defect as an "external crack".Upon reviewing the picture and a video provided by the site, ca confirmed an external, palpable, horizontal scratch directly below the velour.The site explained that the scratch was first noticed the night prior and had grown in length.Therefore, bhi ca advised trimming the cannula above the defect, and adding in a connector and an extension set.Bhi ca also advised doing this on both sides of the pump to ensure adequate length on both sides of the cannula.Of note, the site chose to trim the affected section of the cannula and added only one connector.After the cannula was trimmed the pump level was observed to be even and the cannula integrity issue was resolved.The excor blood pump continued to function as intended, maintaining full fill and ejection throughout.At the time of the event, the length of the cannulas were not symmetrical, but the distance between the titanium connectors were within the recommendations of the ifu.The excor cable ties were positioned per the ifu, and there were no previous damage or modifications to the cannulas or connectors noted.
Additional Manufacturer Narrative
The excor apex cannula (lot no.00144482) was placed on the patient (b)(6) 2024 and remains on the patient to date.The event occurred on 2026-02-05, which is (404 days) after the cannula was placed on the patient being supported with an excor active driving unit.The affected part of the cannula was trimmed off and only a connector was added.The site notified berlin heart that the surgeon trimmed the cannula directly through the affected area, and was discarded.We have reviewed the device history record (dhr) of the cannula lot no.00144482.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 implanted on five patients.Four patients were successfully transplanted.There are no other complaints associated with either lot number.

• Brand Name: EXCOR®
• Common Device Name: VENTRICULAR (ASSIST) BYPASS
• Manufacturer (Section D): BERLIN HEART INC.; 9391 grogan's mill road; suite a-6; the woodlands TX 77380
• 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: 24459363
• Report Number: 3004582654-2026-00011
• Device Sequence Number: 18546953
• Product Code: DSQ
• UDI-Device Identifier: 04260090040515
• UDI-Public: (01)04260090040515(17)270611(10)00144482
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

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: C18A-020
• Device Lot Number: 00144482
• 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: 02/05/2026
• Initial Report FDA Received Date: 02/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/10/2024
• 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: 16 MO
• Patient Sex: Female
• Patient Weight: 4 KG