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

Model Number	C80G-021M
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	Air Embolism (1697); Death (1802)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The clinic provided images of the arterial cannula which was used on the patient at the time of the incident where a breach was noted on the outflow side at the region of transition from the arterial cannula to the pump connector.The images were taken following explant and presumably after cleaning.The clinic performed an exchange of the blood pump and shortening of the affected cannulae on (b)(6) 2019.A potential disruption of the cannula in relation to this adverse event is to be investigated.Berlin heart reviewed the production records of the excor cannula in question, lot: 00073814.This cannula was produced according to our specification.The excor cannula, lot: 00073814, was implanted on (b)(6) 2018 and explanted on (b)(6) 2019 at the time of the reported event (307 days).The blood pump and cannulae in use by the patient at the time of the adverse event will be returned to the manufacturer.An updated follow-up report will be provided following a detailed investigation.
Event or Problem Description
We were contacted by the clinic via the hotline regarding a adverse event involving an excor patient supported in the lvad configuration.The clinic reported an air embolism in the patient.Consequently, the patient suffered an extensive hypoxic brain injury and vad support was withdrawn on (b)(6) 2019.
Additional Manufacturer Narrative
The piece of the affected cannula where the defect occurred was returned to the manufacturer on 2019-09-04.These pieces were received with the blood pumps, the pieces were left on the connector of the blood pumps.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.The origin of the rupture cannot be clearly clarified.However, based on investigation finding such as the displacement of the cannula position on the connector and the different impressions seen on the inside as well as outside of the cannula, it can be assumed that high tensile forces must have acted on the cannula.Such a one-sided displacement of a cannula under the cable ties can only occur by massive kinking of the cannula close to the connector edge.It cannot be confirmed with certainty whether additional external impacts were also present that contributed to the damage scenario.During the analysis inner surface damages were detected in different places.Such inner damages can also be induced during a pump exchange (5 pump changes were carried out on the affected cannula in the period from 03.10.2018 to 05.08.2019).The instruction for use (ifu) advises to shorten the cannula in a case of pump exchange and to use the cannula extension set, if needed.On 2019-10-07, the investigation results were discussed with the clinic and the clinic staff was re-trained on the handling of the excor system with special regard to the handling of pump exchanges.

• 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: 8950605
• Report Number: 3004582654-2019-00074
• Device Sequence Number: 14145491
• Product Code: DSQ
• UDI-Device Identifier: 04260090041352
• UDI-Public: 04260090041352
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date (Section B): 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2021
• Device Model Number: C80G-021M
• Device Lot Number: 00073814
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 08/05/2019
• Initial Report FDA Received Date: 08/30/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 1 YR