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

Model Number	C80G-021X01
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/13/2017
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).Berlin heart reviewed the production records of the excor cannula, lot 00049940.This cannula was produced according to our specification.The excor cannula, lot 00049940, was implanted on (b)(6) 2016 and explanted on (b)(6) 2017 (days).Upon receipt of the affected product, pictures were taken as received; the cannula was in two separate pieces: cannula head and cannula body.The method of fractography was used for further investigation of the returned excor cannula.An examination of the fractured cannula head and cannula body indicated that the two fracture surfaces were mirror images of each other which meant that the damaged area was completely present, with no piece missing between them.The characteristics of the fracture surfaces seen are typical of the slow development of a fracture, beginning from a recognizable needle puncture at the initial damage site.At the location of the initial damage, an oblique puncture was visible which converged v-shaped at the tip.The pictures provided to us by the clinic, also indicate that the cannula was radially broken at the curvature of the cannula head.No adherent deposits could be seen on the large fracture surfaces.However, a fixed deposit was visible in the puncture channel at the initial damage.From this initial puncture, cracks ran in two directions along the cannula circumference.Based on this finding during the evaluation, it appears that the cannula was most likely initially damaged on its outer side by a needle or sharp object when the chest was closed after implantation of the device on (b)(6) 2016.With time, the initial damage progressed slowly due to repeated internal load and resulted in a local bleeding (e.G., hematoma, pseudo-aneurysm),rupturing completely only during re-opening of the chest on (b)(6) 2017.The increased bleeding in the wound could be the extension of this intra-thoracic bleeding.The patient developed cerebral bleeding and neurological dysfunction confirmed by ct after the event.We were informed by our distributor at the time of this report that the patient is stable but with a noticeable degree of neurological dysfunction.
Event or Problem Description
Berlin heart (b)(4) was informed by our (b)(6) distributor that an excor blood pump patient supported in the lvad configuration experienced minimal bleeding at the cannula exit site.The bleeding started on (b)(6) 2017.The clinic suspected an injury at the exit site and kept the bleeding under observation.On (b)(6) 2017, the bleeding increased progressively and the patient was taken to the or urgently for surgical exploration.When the chest was opened in the or, there was extensive blood loss.Once the patient was stabilized, an inspection of the arterial excor cannula revealed a fracture of the cannula very close to the aortic anastomosis.The affected excor cannula and blood pump were exchanged by trained personnel at the clinic.Berlin heart was informed of the event at this time.

• 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: 6786403
• Report Number: 3004582654-2017-00020
• Device Sequence Number: 1039016
• 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
• Device Implanted Year: 2016
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 08/10/2017

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: 12/31/2018
• Device Model Number: C80G-021X01
• Device Catalogue Number: C80G-021X01
• Device Lot Number: 00049940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/21/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/10/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 9 MO