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

Model Number 10016#AVALON ELITE 16F, 14CM

Device Problem Unintended Movement (3026)

Patient Problem Cardiac Tamponade (2226)

Event Date 12/17/2019

Event Type  Injury  

Event Description

The customer reported: a (b)(6) kg patient who went on vv ecls through the neck with a 16f avalon.It was in the correct position and working well.After 5 days, the patient was proned and the cannula migrated.It was half as effective, but the patient was going to come off ecls the next day, so the decision was to leave it rather than coming off and re-positioning.The patient failed to wean the next day and left on.During the night, the cannula punctured the right atrium and caused a tamponade.The patient was opened and re-cannulated centrally to va ecls.After 2 days, the patient was weaned and remains stable.(b)(4).

Manufacturer Narrative

A review for complaints with similar reported failures, which were investigated and confirmed, was performed and no complaints were found.A medical review was performed by manager medical affairs on 2020-03-13 with the following result: evaluation: interaction and irritation between the catheter and the surrounding vascular structure the clinical choice of the catheter/cannula dimension comply mainly with the calculated nominal blood flow (pump flow), the pressure drop across the catheter/cannula and the vascular hence vessel dimensions of the respective patient.The assessment of the clinicians is based on the sonography hence imaging technique.To some extend is it just a snapshot of the physiology of the patient that may change throughout the course of the extracorporeal circulation (ecc).Among other aspects is this related to the volume status of the vascular system and the drugs that influence the physiological vessel constriction or dilation.The larger the dimension of the respective catheter is the higher is the space occupying and the more likely it is that the exposed vessel gets in contact or interacting with the catheter device.This applies in particular during repositioning maneuvers of the patient and repositioning of the catheter.Although the catheter implantation is being monitored with imaging processes it is conceivable that the catheter interacts with the surrounding vessel wall.This interaction can occur during the protrusion of the catheter whilst the catheterization, during mobilization or patient positioning / re-positioning or remotely throughout the entire residence time of the catheter over the course of the ecls procedure.The decision about the indication for repositioning the patient under ecls is in the responsibility of the physician in charge in order to meet best practice and clinical protocols.Summary of relevant information: the application of the device in scope (avalon elite dlc 16 fr.) as the interface between the patient and the corresponding ecmo device was reported to work well and be in correct position for the first 5 days.During shifting of the patient into prone position the right atrium of the patient with the weight of 6 kg was punctured.Chest x ray and epicardial transesophageal echocardiogram (tee or rather toe) were deployed after the reposition.According to the report actions were taken in order to prevent catheter migration.No data was provided about taken actions that could prevent the device from migrating during the planned and conducted patient reposition maneuver into prone position.No information about the skin fixation prior and during the reposition maneuver was provided.Conclusion: the claimed device is unavailable for investigation.The malfunction of the claimed device can be excluded as the report states that the catheter was working well in its initially position.The actions that were taken to prevent the catheter from migrating were not explained by the customer.The incident has occurred during patient repositioning into a prone position.To what extent the skin fixation has contributed to the puncture of the right atrium is unknown.It is not reproducible whether the maintenance of the skin fixation led to a strain (torsion) or bend of the device.There is no indication about what exactly led to the tamponade during the repositioning of the patient, therefore no conclusive root cause could be determined.A probable root cause could have been that the spatial positional change of the prone position did increase the load of the catheter surrounding tissue to the catheter tip.In this regard a use error cannot be excluded.Additionally or in separation a torsional stress could also have promoted or triggered the claimed incidence.The reported failure could not be confirmed.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.The occurrence rate was calculated for the reported issue 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.H3 other text : the sample was scrappped by the hospital.

Event Description

Internal ref#: (b)(4), one support: 83825.

• Brand Name: CATHETERS & CANNULAE
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9694575
• MDR Text Key: 180524297
• Report Number: 3008355164-2020-00002
• 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: 03/27/2020

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: 10016#AVALON ELITE 16F, 14CM
• Device Catalogue Number: 701063533
• Device Lot Number: 246799
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/27/2020
• Distributor Facility Aware Date: 02/10/2020
• Event Location: Hospital
• Date Report to Manufacturer: 03/27/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/11/2020
• Supplement Dates Manufacturer Received: 03/13/2020
• Supplement Dates FDA Received: 04/02/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 6