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

Model Number	C18A-020X01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Death (1802)
Date of Event	11/15/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have reviewed the production records of the excor apex cannula with lot.No.00063702.This cannula was produced according to our specification.The affected cannula, lot.No.00063702 was in use from 2019-03-26 until 2019-11-18 ((b)(6)).The affected cannula in use by the patient at the time of the incident was returned to the manufacturer.An updated report will be provided following a detailed investigation.
Event or Problem Description
Berlin heart inc.Was informed about an incident involving the apex cannula of an excor patient supported in the lvad configuration.The clinic reported that the apex cannula was disrupted during a pump exchange, resulting in blood loss.Additionally, air entered the blood pump and the aortic cannula.The patient went into cardiac arrest.Cpr was performed until the new pump was placed on and normal sinus activity was regained.The new pump was connected and the pump and cannula de-aired.The patient was taken to have a head ct which revealed 2 large frontal lobe ischemic events.The patient was deemed to no longer be a transplant candidate and the parents wished to withdraw support.On 2019-11-19, the clinic reported that the patient was withdrawn from support and the patient died on (b)(6) 2019.The affected cannula will be returned to the manufacturer for further investigation.
Additional Manufacturer Narrative
A piece of affected cannula where the defect occurred was returned to the manufacturer on 2019-12-03.During the investigation by berlin heart, only non-destructive microscopic imaging and ct scans were performed.All analyses were completed by two independent investigators.The ct scans were performed at an external independent laboratory under the observation of the manufacturer.Based on the location of the rupture.It can be assumed that the examined inflow cannula was damaged by a sharp-edged object.The clinic reported loosening the cable ties near the location of the rupture.The instructions for use for the excor vad system, revision 12 includes several warnings cautioning the user against touching the blood pumps, cannulae and driving tubes with pointed or sharp objects.On 2019-12-19, the clinic was re-trained on the handling of the excor system with special regard to the handling of pump exchanges.

• Brand Name: EXCOR APEX CANNULA FOR SMALL CHILDREN
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 9446600
• Report Number: 3004582654-2019-00093
• Device Sequence Number: 2210121
• Product Code: DSQ
• UDI-Device Identifier: 04260090040515
• UDI-Public: 04260090040515
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: P160035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2019

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: 03/31/2020
• Device Model Number: C18A-020X01
• Device Catalogue Number: C18A-020X01
• Device Lot Number: 00063702
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2019
• Initial Date Received by Manufacturer: 11/15/2019
• Supplement Date Received by Manufacturer: 11/15/2019
• Initial Report FDA Received Date: 12/10/2019
• Supplement Report FDA Received Date: 01/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 8 MO