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 Consequences Or Impact To Patient (2199)
Date of Event	11/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
We have reviewed the production records of the excor apex cannula with lot.No.00074691.This cannula was produced according to our specification.The affected cannula, lot.No.00074691, was in use from (b)(6) 2019 until (b)(6) 2019 (222 days).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 our investigation findings, it appears that a puncture to the cannula was caused by a narrow, sharp and pointy object, which was introduced from the outside of the cannula.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.
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 a hole in the apex cannula with alarming from the ikus "check left pump and driving tube".The clinic briefly switched to the hand pump and then decided to clamp the cannulae and perform a pump exchange.On (b)(6) 2019, the clinic reported that the patient was clinically stable.The affected blood pump and a piece of the affected cannula was returned to the manufacturer for further investigation on (b)(6) 2019.On (b)(6) 2019, we were informed by the hospital the patient is completely back to base line.

• 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: 9404880
• Report Number: 3004582654-2019-00090
• Device Sequence Number: 1711399
• 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,user facility
• Initial Reporter Occupation: Physician
• Remedial Action: Replace,Modification/Adjustment
• Type of Report: Initial
• Report Date (Section B): 12/03/2019

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: 05/31/2021
• Device Model Number: C18A-020
• Device Catalogue Number: C18A-020
• Device Lot Number: 00074691
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2019
• Initial Report FDA Received Date: 12/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 7 MO
• Patient Weight: 7