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 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

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 (b)(6).It was reported that the inner cylinder (introducer) of the 10023#avalon elite 23f, 31cm was pulled out and customer tried to inserted it again during procedure but it could not be inserted again.The patient was infected with covid 19 and therefore the product is not available for investigation.No harm to any person has been reported.Complaint id:(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in japan.It was reported that the inner cylinder (introducer) of the 10023#avalon elite 23f, 31cm was pulled out and customer tried to inserted it again during procedure but it could not be inserted again.The patient was infected with covid 19 therefore, the product is not available for investigation.No harm to any person has been reported.The affected avalon elite® bi-caval dual lumen cannula was not any longer available therefore, no technicial investigation in the getinge laboratory could be performed.A review of the complaint data for similar complaints was performed but no confirmed complaint with a potential root cause was found.Based on the information available at this time the reported failure could not be confirmed.However, the failure mode "introducer can´t be inserted after removal" can be linked to the following most possible root causes according to our risk management file: mechanical damage of catheter or introducer during insertion of introducer.A device history review (dhr) was performed for the affected cannula and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Production related influences can be excluded.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.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: 13768800
• MDR Text Key: 287199920
• Report Number: 8010762-2022-00084
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K130639
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 06/01/2022

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
• Device Lot Number: 270132
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/15/2022
• Supplement Dates Manufacturer Received: 05/31/2022
• Supplement Dates FDA Received: 06/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Male