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

Model Number 10023#AVALON ELITE 23F, 31CM

Device Problem Difficult to Insert (1316)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturer has received the affected product but the investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that the avalon elite cannula had issue with the obturator.The obturator could not be separate from the cannula upon attempted insertion.The cannula was used for patient treatment.Another cannula was used to complete the treatment without incident.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the avalon elite cannula had issue with the introducer.The introducer could not be separate from the cannula upon attempted insertion.Another cannula was used to complete case without incident.No harm to any person has been reported.The affected avalon elite cannula, 23fr.Was investigated in the getinge laboratory on 2022-10-05 with the follwing results: the cannula was visual inspected and no scratches, cracks or breaks are detected.However, the visual inspection could confirmed that the cannula and the introducer were bent.During the investigation the introducer was checked manually for movement in the cannula.The introducer shows deformations which led in the laboratory functional test to a higher applied force to insert and remove the introducer from the cannula.The dimensions of the outer diameter of the introducer are within the tolerances 4,572 mm +/- 0,07.The reported failure "introducer can´t be removed" could be confirmed and the most probable root could be determined as a wrong user interaction by deforming the introducer before application of the device.Based on the investigation results the reported failure "introducer can´t be removed" could be confirmed however, the dimensions of the outer diameter are within the tolerances.The lot number was not provided by the customer.However, a generic dhr review of the catheter reflects controls to inspect dimensional and visual attributes of the catheter before packaging has been performed by nordson on 2022-10-07.No anomalies were found for any subassembly or final assembly.Production related influences are unlikely to have contributed to the reported failure.Medical assessment is requested but still ongoing.

Event Description

Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported failure and the application method described by the customer was evaluated by getinge medical affairs on 2022-11-02 with the following outcome: based on the data obtained from the complaint report as well as the investigation report, a malfunction of the avalon elite dual lumen catheter and corresponding introducer can likely be excluded to be the cause for the problems of the customer to remove the introducer from the cannula.The outer diameter of the introducer was inspected by the life cycle team of getinge and it was confirmed that it is within the tolerances.It can therefore be ruled out that the problems when removing the introducer from the cannula were triggered by wrong dimensions of the introducer.The investigation report also stated that the cannula and introducer had a bend when it was taken out from the bio container.However, this is most likely since the cannula and introducer have to be slightly bent because of their length in order to fit into the bio container.Furthermore, there were approximately 4 months between the incident and the arrival of the product for examination.It is unclear how the cannula and associated introducer were stored in the interim.Basically, the introducers are protected from bending and flexing in the packaging with a barrel and tip protector.After removing the cannula and introducer from the packaging, the user must check the product for defects as well as its function before use.It is also important that the cannula is moistened before usage.Afterwards it has to be checked whether the introducer can be moved easily in the cannula.If the cannula is not moistened, the problems described by the customer may occur.Furthermore, if the introducer is pushed into the cannula with too much force, it may become stuck at the tip of the cannula as the introducer becomes wider from the tip upwards.Based on the above, there is no indication that the avalon elite dual lumen catheter or introducer were associated with, or caused, the event.The likely root cause may originate in the technique of introducer insertion into the cannula.Last, no patient harm was reported.In order to avoid reoccurrence of the reported event the customer will be informed by the getinge sales and service unit (ssu) to follow the chapter in the instruction for use avalon elite® bi-caval dual lumen catheter g-158 v04 5.3 safety information for catheter: do not use deformed catheters.Do not attempt to bend deformed catheters back into their original shape.Chapter 7 application: moisten the introducer completely with physiological saline solution (0.9%) immediately before use prior to inserting it in the catheter.Insert the introducer into the drainage lumen of the catheter and fully engage the cap onto the connector.Check the mobility of the introducer before using the catheter.It must be possible to move the introducer freely and without hindrance.When inserting the introducer into the catheter, ensure that the line marking disappears completely into the cap.In this way, the minimum insertion depth of the introducer is achieved.To remove the introducer, it must not be inserted too far into the catheter.Observe the depth markings on the introducer during insertion.The catheter can be introduced either into the previously exposed vessel under visual control along the guide wire or percutaneously using the seldinger technique.The choice of insertion technique is at the physician's discretion on the basis of his or her experience.Take the components for implementing the seldinger technique from the separate insertion kit and observe the corresponding instructions for use.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.

• Brand Name: CANNULA & CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15549929
• MDR Text Key: 303398358
• Report Number: 8010762-2022-00400
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/03/2022

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
• Device Operator: Health Professional
• Device Model Number: 10023#AVALON ELITE 23F, 31CM
• Device Catalogue Number: 701063536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/08/2022
• Initial Date FDA Received: 10/06/2022
• Supplement Dates Manufacturer Received: 10/06/2022; 11/02/2022
• Supplement Dates FDA Received: 10/27/2022; 11/04/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1