MAUDE Adverse Event Report: BERLIN HEART GMBH ARTERIAL CANNULA FOR SMALL CHILDREN, Ø6MM; VENTRICULAR ASSIST DEVICE

Model Number	C80G-021
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/14/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Exemption number: e2013009.Berlin heart inc.(importer number:(b)(4)) is submitting the report on behalf of berlin heart gmbh (manufacturer).We have reviewed the production records of the excor cannula, lot 00038680.This cannula was produced according to our specification.The excor cannula, lot 00038680, was implanted on (b)(6) 2016 and remains in use following the removal of the compromised section.The defective, trimmed off section of the cannula was not provided to the manufacturer for analysis.The pictures provided by the clinic are not sufficient to identify the cause of the damage to the cannula.However, email communication from the distributor,indicate that the patient's mother noticed the leakage only when the patient was kinking the cannula.In the current instructions for use (ifu), the user is advised that the cannula section must not be bent at the transition to the connector region or at the transition to polyester velour section, since this could lead to the damage of the cannula.Furthermore, the user is advised to ensure that the cannulae are not subjected to any tension, torsion, pressure or traction.And further on, in the manual the user of excor is instructed to inspect the blood pumps and cannulae regularly.
Event or Problem Description
We were informed by our distributor in (b)(4), that the clinic noted some minimal damage in the arterial cannula of the right excor blood pump of a patient supported in the bvad configuration.A small tear was identified in the silicon that led to the leakage of a minimal amount of blood.Trained personnel at the clinic trimmed off the compromised section of the cannula.The site reported that the patient was not negatively affected by the incident and is doing well.

• Brand Name: ARTERIAL CANNULA FOR SMALL CHILDREN, Ø6MM
• Common Device Name: VENTRICULAR ASSIST DEVICE
• Manufacturer (Section D): BERLIN HEART GMBH; wiesenweg 10; berlin, 12247 ; GM 12247
• MDR Report Key: 6405924
• Report Number: 3004582654-2017-00009
• Device Sequence Number: 318109
• Product Code: DSQ
• UDI-Device Identifier: 04260090040393
• UDI-Public: 04260090040393
• Combination Product (Y/N): N
• Initial Reporter Country: AR
• PMA/510(K) Number: H100004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 03/15/2017

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: 09/30/2017
• Device Model Number: C80G-021
• Device Catalogue Number: C80G-021
• Device Lot Number: 00038680
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/15/2017
• Initial Report FDA Received Date: 03/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 YR