MAUDE Adverse Event Report: BERLIN HEART GMBH EXCOR ARTERIAL CANNULA FOR INFANTS; VENTRICULAR ASSIST DEVICE

Model Number	C80G-040M
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/19/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The cannula (lot no.00105230) was in use on the patient until the time of the event on (b)(6) 2024(535 days).The affected patient was on active driver.Based on information available, two pump changes were performed prior to the reported event occurred.According to the information provided by the site, the cannula in question was shortened at least twice during this period and each time cannula was shortened approximately by 1.5 cm.Subsequently, at time of this event the length of the cannula without a velour, appears to be much shorter than the recommended 5 cm minimum length per the field safety notice ds-23-01.We have reviewed the production records of the excor aterial cannula lot no.00105230.This product was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
Berlin heart gmbh was informed by the clinic that a cannula breach on a patient supported in lvad configuration on the excor active driver.The breach occurred on the outflow cannula at the junction of silicone and velour.The vad was disconnected and cpr performed.Cpr was effective and the patient was placed on ecmo.On (b)(6) 2024 the patient was converted back to a berlin heart excor pump.The ct result showed that the patient's brain and other organs are functioning normal and the patient is recovering well.
Additional Manufacturer Narrative
The clinic provided berlin heart with a photo of the cannula at the time of the event.The photo from the clinic shows that the cannula had been significantly shortened.The pump connection is directly at the transition between the silicone and velour.The cannula breach reported in this complaint occurred exactly at this location.Per the clinic, the affected cannula had previously been shortened due to a scratch.During visual inspection of the returned cannula (piece of tube), the cannula breach was confirmed.The transition area from cannula to velour represents a cross-sectional change.In the case of cross-sectional changes, excessive stress occurs as a result of the notch effect.If the distance between the velour and the connector is too short, the movement space required to distribute the tensile and compressive stresses that occur is so severely restricted, that the stresses are concentrated in the transition area.This area thus has the effect of a nominal breaking point.The manufacturing documentation (dhr - device history record) of the cannula c80g-040m with the lot number 00105230 was reviewed and confirmed that this cannula was produced according to our specification.No deviations were found.The clinic also mentioned that despite stable support, there was frequent kinking of the cannula, resulting in an average of 100 low flow alarms per day.It can be assumed that the cannula had been stretched several times.Possibly due to excessive external forces during routine examinations or changing the blood pump and/or the connecting set.This could have led to increased internal material stresses in the silicone of the cannula wall and caused the fracture due to tensile stress.Due to the remaining length of the distal end of the cannula without the polyester velour coating, the flexibility of the cannula wall was severely restricted, which must have led to increased internal material stresses in the silicone of the cannula wall and most likely resulted in breakage due to external buckling and/or tensile stresses.

• Brand Name: EXCOR ARTERIAL CANNULA FOR INFANTS
• Common Device Name: VENTRICULAR ASSIST DEVICE
• 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: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 19000612
• Report Number: 3004582654-2024-00020
• Device Sequence Number: 15341137
• Product Code: DSQ
• UDI-Device Identifier: 04260090041369
• UDI-Public: 04260090041369
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse
• Remedial Action: Patient Monitoring
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2024

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: 02/28/2024
• Device Model Number: C80G-040M
• Device Catalogue Number: C80G-040M
• Device Lot Number: 00105230
• 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: 03/20/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Supplement Report FDA Received Date: 07/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• 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: 11 KG