MAUDE Adverse Event Report: BERLIN HEART GMBH ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM; VENTRICULAR ASSIST DEVICE

Model Number	C80G-021
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have reviewed the production records for the excor arterial cannula with lot.No 00078711.This cannula was produced according to our specification.The affected cannula, lot.No.00078711 was in use from 2019-04-23 until 2020-07-22 (456 days).However, the end of this cannula was trimmed 2 ½ months prior to this, due to a similar incident.Evaluation of the prior incident determined that user error caused the breach of the cannula, see mdr 3004582654-2020-00028.The manufacturer recommended an exchange of the cannula.The affected cannula in use by the patient at the time of the incident has not yet been returned to the manufacturer.An updated report will be provided following a detailed investigation.
Event or Problem Description
We were informed by our (b)(6) distributor about an incident involving the arterial cannula of an excor patient supported in the lvad configuration.The distributor reported that a small amount of blood was emerging from the arterial cannula.The affected cannula was shortened by trained specialist personnel in the clinic and the excor blood pump was replaced.The patient was not negatively affected by the incident and we were informed that the patient is doing well after the shortening of the cannula and exchanging the blood pump.
Additional Manufacturer Narrative
The first visual examination revealed a breached in the inflow cannula transverse to the direction of flow, confirming the customer's complaint.The breach is located in the edge area of the velour.The size of the breach is only a few millimeters.There is no damage or markings on the titanium connectors.A imprint can be seen on the outside surface of the cannula.The imprint is circumferential and was most likely caused by the cable tie while fixing the cannula to the connector.This suggests that the cable tie was placed very close to the velour.The cause of the breach is most likely due to connecting the pump in an unfavorable position.In addition, by shortening the cannula before, the position of the connection was moved closer to the skin conduit, where the stresses such as bending, kinking and torsion are unfavorably increased by the patient's mobility.All in all, this led to the inflow cannula breaking in the edge area of the velour.The instructions for clinical use 1000477x06 revision 5 cautions the user against shortening the cannula in such a way that it overlaps with the velour, the ifu recommends the use of an extension set in such a case.Also the ifu cautions the user against applying any tension, torsion, pressure or traction on the cannulae.
Additional Manufacturer Narrative
G3 was correct.It is foreign distributor, not study distributor.

• Brand Name: ARTERIAL CANNULA FOR SMALL CHILDREN, 6MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 10379777
• Report Number: 3004582654-2020-00030
• Device Sequence Number: 2259607
• Product Code: DSQ
• UDI-Device Identifier: 04260090040393
• UDI-Public: 04260090040393
• 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: distributor,foreign,study
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/07/2020

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: 03/30/2021
• Device Model Number: C80G-021
• Device Catalogue Number: C80G-021
• Device Lot Number: 00078711
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/22/2020
• Supplement Date Received by Manufacturer: 07/22/2020; 07/22/2020
• Initial Report FDA Received Date: 08/07/2020
• Supplement Report FDA Received Date: 08/07/2020; 09/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 17 MO