MAUDE Adverse Event Report: BERLIN HEART GMBH APEX CANNULA FOR CHILDREN; VENTRICULAR ASSIST DEVICE

Model Number	C22A-004
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor cannula, lot no.00084068 was in use by the patient from (b)(6) 2020 until the time of the event (b)(6) 2021 (664 days).We have reviewed the production records of the excor cannula, lot no.00084068.This cannula was produced according to our specification.The investigation is still ongoing and a detailed investigation report will be provided as soon as it is available.
Event or Problem Description
We were informed by the distributor about a small breach in the inflow cannula of a patient supported with the excor pediatric in the lvad configuration.The clinic reported a small amount of blood leaking from the cannula in the area of the blood pump connector.The cannula was disconnected from the blood pump and the portion of the cannula where the blood was leaking was removed and the blood pump was exchanged by trained specialist personnel in the clinic.The patient was not negatively affected by the incident.Shortly before the detection of the breach in the cannula, the site reported that the patient had an epileptic seizure and fell down which caused severe kinking of the cannula.
Additional Manufacturer Narrative
During initial visual examination of the returned products a defect at end of the inflow cannula transverse to the flow direction was detected.The breach was located above the edge of the connector, under the edge of the first cable tie.A ct scan was done for both cannula ends (inflow & outflow).The results of the ct scan confirmed the defect at the end of the inflow cannula.The geometry and the structure of the breach in the cannula wall, leads to the assumption that a high external impact on the cannula wall and the connector edge occurred.Further detailed investigation showed multiple traces on the inner surface of the cannula due to strong overload at the end of the inflow cannula.Additionally, it can be noted, the cannula might have been stretched several times caused by moving the pump upright from the patient's body, this may have occured during excessive movement from the patient.It also observed that the position of the cable tie at the time of investigation, was not as recommended in the ifu.These could have led to increased internal material stresses in the silicone of the cannula wall and may have reduced the flexibility of the cannula wall due to external kinking and/or tensile stress.The geometry and the structure of the breach in the cannula wall, leads to the assumption that a high external impact on the cannula wall and the connector edge occurred.This could be in relation to the epileptic seizure of the patient and the circumstance of a fall to the ground.

• Brand Name: APEX CANNULA FOR CHILDREN
• Common Device Name: VENTRICULAR ASSIST DEVICE
• 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: dudley rajapaksa ; 9391 grogan's mill road; suite a-6; the woodlands, TX 77380 ; 2818639706
• MDR Report Key: 13236042
• Report Number: 3004582654-2022-00005
• Device Sequence Number: 14554245
• Product Code: DSQ
• UDI-Device Identifier: 04260090040492
• UDI-Public: 04260090040492
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/12/2022

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: 05/31/2022
• Device Model Number: C22A-004
• Device Catalogue Number: C22A-004
• Device Lot Number: 00084068
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2021
• Supplement Date Received by Manufacturer: 12/13/2021
• Initial Report FDA Received Date: 01/12/2022
• Supplement Report FDA Received Date: 02/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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: 8 YR
• Patient Sex: Female