MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH AVALON ELITE CANNULA & CATHETER; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 10031-CE#AVALON ELITE 31F, 31CM

Device Problems Fracture (1260); Difficult to Advance (2920)

Patient Problem Death (1802)

Event Date 12/03/2020

Event Type  Death  

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

Breakage of the first correctly inserted cannula at the attachment point, necessitating replacement.When the second cannula was inserted, the complication arose despite all precautionary measures (including monitoring with transoesophageal echo).Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a first avalon cannula was correctly inserted and broke at the attachment point, necessitating replacement.The second cannula was inserted using all precautionary measures (including monitoring with transoesophageal echo).But the patient suffered pericardial effusion leading to resuscitation and death of the patient.The customer was not able to confirm which cannula lot# was used first.Device history record review: the production records of the affected cannulas (lot# 239025 and 249693) were reviewed on 2021-01-29.According to the final test results, all tests were passed as per specifications.Production related influences can be excluded.Technical investigation: only the first cannula (cracked connector) was available for return.The avalon cannula with the broken connector was investigated in the getinge laboratory on 2021-02-15.During visual inspection cracks at the blood outlet connector could be confirmed as well as streaks at the blood inlet connector.The cracks could be caused by an unknown application failure.Supplier investigation: the technical investigation results were analyzed by the supplier nordson medical on (b)(6) 2021.As there are no similar complaints reported to them about material failure on pu cannulas and as the cannulas passed a 100 % in-process control a material failure could be excluded.Medical review: for further investigation a medical review was performed by getinge medical experts on (b)(6) 2021 with following results: as reported in the complaint, after insertion, the ¿[return] leg of the cannula was rinsed with a gastric tube syringe¿ which was attached directly to the connector.Insertion of the gastric syringe into the return connector may have created a condition that fractured the connector, forcing the user to exchange the product for a second cannula.Further, unexpected torque in a severe direction may have exacerbated connector fracture.The cardiac perforation likely occurred during the replacement of the initial cannula with the second cannula.While it was stated that imaging was used during the initial and secondary insertions, no mention was made of the use of the required guidewire during the insertion of the second cannula.It was stated in correspondence; however, that the guidewire was in the proper resting location, but not that a guidewire was used during insertion of the second cannula.The assumption is that the guidewire was used before insertion of second cannula; however, if a guidewire was not present during cannula insertion, perforation of a surrounding structure is possible.Pericardial effusion caused by insertion of a dual lumen cannula is a rare but known complication of internal jugular vein insertion.Pericardial effusion may occur by misplacement of the guidewire and/or the cannula leading to injury to surrounding structures: if the wire is not inserted far enough, the dilator and cannula will remain without guidance from a certain point onwards.A dilator and cannula advanced without proper guidance may pierce the myocardium.If the wire is not guided into the inferior vena cava but deviates into the right ventricle, the dilator and cannula will follow the wire into the right ventricle and may cause injury to the right ventricular myocardium.If the wire pierces any of the veins and venous confluences it must pass on its way into the right atrium, it may leave the vascular space, which will result in bleeding from a vessel perforation.If a dilator and cannula are subsequently introduced along the misplaced wire, a large perforation of the vascular wall will be created.Depending on the location of the perforation, this may also result in pericardial effusion.Based on these investigation results the failure ¿connector cracked¿ of the first cannula could be confirmed.According to the risk management file of the product avalon cannula the most probable root cause is a mechanical damage due to excessive force (e.G.Wrong handling, kinking, lack of attention).Further no product related malfunction of the second cannula could be confirmed which could have led to the tissue damage and death.According to the risk management file of the product avalon cannula the most probable root cause is a handling failure (e.G.Missing or wrong used guide wire, lack of attention, too much force used).The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: AVALON ELITE CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10992481
• MDR Text Key: 220946031
• Report Number: 3008355164-2020-00025
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 03/08/2021

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
• Device Operator: Health Professional
• Device Model Number: 10031-CE#AVALON ELITE 31F, 31CM
• Device Catalogue Number: 701073609
• Device Lot Number: 249693
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/08/2021
• Distributor Facility Aware Date: 02/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/11/2020
• Supplement Dates Manufacturer Received: 02/23/2021
• Supplement Dates FDA Received: 03/08/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 45 YR
• Patient Weight: 81