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

Model Number	C23V-004M
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Convulsion/Seizure (4406)
Date of Event	04/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor atrial cannula ø 12/9 mm; l 32 cm; head 23 mm (lot: 00119829) was in use on the patient from on (b)(6) 2023 to date.The event occurred on 2025-04-09, which is (758 days) after the cannula was placed on the patient.We have reviewed the production records of the cannula lot no: 00119829 and concluded that this product was produced according to our specification.According to the production records, a total of (b)(4) cannulas with this lot no.Were produced.Out of (b)(4) cannulas, two were distributed and used on patients in (b)(6), two were implanted on patients in (b)(6).The fifth cannula was implanted in usa (subject of this report).There are no more complaints associated with this lot number.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
On (b)(6) 2025, the site contacted (b)(6) inc.Clinical affairs (ca) to report that a call was received from the patient's bedside nurse with concerns about an area on the inflow excor atrial cannula ø 12/9 mm; l 32 cm; head 23mm (lot: 00119829).The implanting surgeon assessed the patient bedside and made the decision to upgrade the patient to icu to excise the concerning area of the cannula.During transport, the patient began having a seizure.After the seizure ended, a drop of blood was noticed on the outside of the cannula at the level of the titanium pump stub.The cannulas were clamped, the affected portion of the cannula and excor blood pump were removed, and the patient was placed on ecmo.The patient was then taken for a head ct which was negative for any acute events.After returning from ct, the site reports that the patient began waking up and was appropriate in movement and speech.The site provided a video of the pump and cannula portion that was removed.On (b)(6) 2025, the patient was switched from ecmo to an excor blood pump.
Additional Manufacturer Narrative
The affected cannula along with the blood pump was returned to berlin heart gmbh.The reported event occurred on 2025-04-09, which is (758 days) after the cannula in question was placed on the patient.During initial visual inspection of the returned section of the cannula, the reported crack was confirmed.The damage was found at the inflow end of the cannula.The affected cannula was clearly exposed to excessive stress, which ultimately led to the damage reported.According to the patient's history, several pump changes were performed over a period of 758 days and it may have contributed to the damage.The damage of the cannula was immediately noticed by a clinic staff and 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: odell roberts ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639712
• MDR Report Key: 21950161
• Report Number: 3004582654-2025-00024
• Device Sequence Number: 15733769
• Product Code: DSQ
• UDI-Device Identifier: 04260090041291
• UDI-Public: (01)04260090041291(17)250331(10)00119829
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2025

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 Expiration Date: 03/31/2025
• Device Model Number: C23V-004M
• Device Lot Number: 00119829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/02/2025
• Supplement Report FDA Received Date: 07/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/19/2022
• 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: 4 YR
• Patient Sex: Female
• Patient Weight: 9 KG