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

Model Number	C18A-020
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The excor apex cannula, s/n (b)(4), was in use by the patient from 2019-02-11 until (b)(6) 2021.We have reviewed the production records of the excor apex cannula, s/n (b)(4).This cannula was produced according to our specification.A detailed investigation report will be provided as soon as it is available.
Event or Problem Description
We were informed by the clinic about a small crack in the apex cannula of a patient supported in the lvad configuration.The clinic reported bleeding from the outflow cannula in the area of the connector.The patient was brought into icu for a transfusion and the shortening of the 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 left the icu shortly after the shortening of the cannula.
Additional Manufacturer Narrative
He excor apex cannula, s/n (b)(6), was in use by the patient from 2019-02-11 until 2021-01-19 (708 days).We have reviewed the production records of the excor apex cannula, s/n (b)(6).This cannula was produced according to our specification.The report from the clinic stated that the affected part of the cannula that was trimmed off and will not be returned to the manufacturer for evaluation.Therefore, the cause of the damage to the cannula could not be clearly identified.The patient had no lasting negative effects and is doing well.In the current instructions for use (ifu), the user is advised that the cannula must not be bent, since this could lead to the damage of the cannula.Furthermore, the user is advised to ensure that the cannula are not subjected to any tension, torsion, pressure or traction.In the ifu, the user of excor is instructed to inspect the blood pumps and cannulae regularly.

• 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: 11267435
• Report Number: 3004582654-2021-00007
• Device Sequence Number: 17154976
• Product Code: DSQ
• UDI-Device Identifier: 04260090040515
• UDI-Public: 04260090040515
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,u
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2021

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: 09/30/2021
• Device Model Number: C18A-020
• Device Catalogue Number: C18A-020
• Device Lot Number: 00078252
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/19/2021
• Supplement Date Received by Manufacturer: 01/19/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 3 YR