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

Model Number	C80G-021M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor arterial cannula (lot no.00145711) was used on the patient from (b)(6) 2025 to date.The damaged portion of the cannula was trimmed off on (b)(6) 2026.The event occurred on (b)(6) 2026, which is (325 days) after the cannula was placed on the patient.The patient is being supported in an off-label configuration, with excor cannulas and connecting/extension sets to a continuous flow device.The affected cannula section is not returned to berlin heart for investigation, as the affected cannula section was already discarded.Therefore, neither the failure nor the cause of the failure in question could be determined.We have reviewed the device history record (dhr) of the cannula lot no.00145711.This product was produced according to our specifications.According to the production records, a total of five cannulas with this lot no.Were produced.All the five cannulas with this lot no.Were distributed in the usa and used on patients.There are no other complaints associated with this lot number.
Event or Problem Description
The site contacted berlin heart inc.(bhi) clinical affairs (ca) via email on (b)(6) 2026 to report that the outflow excor arterial cannula presented with a partial tear.Per the site contact, the perfusionist was inspecting the cannulas and the partial tear in the cannula was noticed.No blood was noted to be leaking from the partial tear.Of note, this patient is on continuous flow, as of (b)(6) 2026, utilizing a excor connecting set ø 6/9 mm on the outflow cannula and a 9/9 mm on the inflow cannula.Per the site, the patient is placed in the prone position as well as upright in a chair on a regular basis for physical therapy.In the picture provided by the site, the cable tie is positioned appropriately.It is important to note that this site does not use the cable ties supplied from the manufacturer, and has been re-educated multiple times on the recommendations, while continuing to use an alternative product.Prior to notifying bhi ca, the site removed the portion below the partial tear and pushed the cannula onto the 6/9 connecting set.Per the site, there is not much distance from the velour to the end of the cannula but are unable to measure at this time due to the occlusive dressing in place.The cannula portion cut off was disposed of prior to notifying bhi.The patient remained hemodynamically stable throughout the event and did not experience any untoward effects.

• 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: 24831198
• Report Number: 3004582654-2026-00021
• Device Sequence Number: 18749454
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: (01)04260090041352(17)270725(10)00145711
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 04/09/2026

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: 00145711
• 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: 03/12/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2024
• 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: Male
• Patient Weight: 8 KG