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

Model Number AVALON ELITE CANNULA & CATHETER

Device Problem Malposition of Device (2616)

Patient Problem Perforation (2001)

Event Date 06/23/2023

Event Type  Injury  

Event Description

A getinge employee was attending a meeting of the advisory board members for getinge cardiopulmonary.One of the guest speakers mentioned in passing that the pediatric-sized avalon elite dual lumen cannulae tend to be too long for some pediatric patients.Further, she mentioned that in some cases (of that subset of patients) the liver was perforated due to the length of the cannula.She also mentioned that the cannula may not position itself in the right location due to its length.No details were given surrounding the statement including patient size, cannulae sizes affected, underlying circumstances, associated congenital anomalies, means of imaging used (ct, echo, etc.), dates of occurrence, patient outcome, or number of cases/events involved.It was a general statement made in the context of a question from the advisory board moderator.Her response to the question of what she wanted in a cannula was one that was variable length to avoid the situation mentioned above.No further details were disclosed while she was speaking.Complaint id: (b)(4).

Manufacturer Narrative

The investigation of the manufacturer is ongoing.H3 other text : 4118.

Event Description

Complaint id# (b)(4).

Manufacturer Narrative

It was reported that a getinge medical affairs specialist was attending a meeting of the advisory board members for getinge cardiopulmonary on 2023-06-23.One of the guest speakers mentioned in passing that the pediatric-sized avalon elite dual lumen cannulae tend to be too long for some pediatric patients.Further, the guest speaker mentioned that in some cases (of that subset of patients) the liver was perforated due to the length of the cannula.She also mentioned that the cannula may not position itself in the right location due to its length.No details were given surrounding the statement including patient size, cannulae sizes affected, underlying circumstances, associated congenital anomalies, means of imaging used (ct, echo, etc.), dates of occurrence, patient outcome, or number of cases/events involved.It was a general statement made in the context of a question from the advisory board moderator.The response to the question of what the guest speaker wanted in a cannula was one that has a variable length to avoid the situation mentioned above.No further details were disclosed while the guest speaker was speaking.Afterwards the information was received that not the liver was perforated, it was the heart.The getinge field service technician send three reminder to the customer and did not received any answer.Therefore no further information could be received.A medical review was performed by getinge medical affairs on 2023-09-26 with following conclusion: "in the course of corresponding with the institution involved in the complaint, the following questions were submitted to the local getinge representative (via the ssu) in an effort to obtain more details about the events described on 23rd june 2023: how many patients are affected? was there any death related to that problem/event? what was(were) the patient size(s)? what was(were) the cannulae size(s)? are there any associated congenital anomalies that may have contributed to the problem of perforation? was imaging used (ct, echo, etc.)? are pictures available of ct/ultrasonic of a wrong cannulae position/wrong length for patient? what were the patient outcomes? what were the event date(s)? was a guidewire used with insertion? are lot numbers of the avalon cannulae used available? as described previously, no details were provided surrounding the circumstances of the events cited by dr.(b)(6).However, a clarifying statement was issued through correspondence stating that the stated perforation involved cardiac structures and not hepatic structures.The assumption is that the events referred to by dr.(b)(6) occurred during initial insertion of the product.Further, no details were provided regarding imaging used during insertion.In correspondence with the complaint institution, it was divulged that the events involved the 13 french avalon elite cannulae.Last, the dispositions/outcomes of the patients involved were not divulged.The complaint narrative states that during the presentation, the perforation was related to the length of the cannula.However, no details were provided regarding patient size, anatomy, use of a guidewire, use of imaging, etc.That said, it is challenging to attribute the stated events to a product deficiency/design or diminution in performance.This, in the context of few details regarding the cannulation process and patient demographics.While no mention was made of either using, or not using, imaging, the instruction for use strongly recommends imaging to promote and assure proper advancement, insertion, and placement of the guidewire and the cannulae.Because the institution attends to pediatric and/or neonatal sized patients, a likely root cause for the described scenario may be more closely related to attending patient population and the challenges that are present within that population.Small body habitus, difficult vascular anatomy, irregular congenital structures, and other anatomical irregularities in that population may complicate the cannulation process." based on the results the reported failure "avalon cannulae to long" could not be confirmed.This complaint was found in the database of customer complaints for the avalon cannula as a single event (timeframe from 2022-06-23 till 2023-06-23).The customer will be informed about the results by the getinge sales and service unit.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 : device already discarded by customer.

Manufacturer Narrative

On 2023-08-14 the information was received that instead of the liver the heart was perforated.A follow-up medwatch will be submitted when additional information becomes available.H3 other text : device already discarded by customer.

Event Description

(b)(4).

• Brand Name: AVALON ELITE DUAL LUMEN 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: 17245602
• MDR Text Key: 318270830
• Report Number: 8010762-2023-00312
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/27/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: AVALON ELITE CANNULA & CATHETER
• Device Catalogue Number: UNKNOWN
• Device Lot Number: NOT KNOWN
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 06/23/2023
• Initial Date FDA Received: 07/03/2023
• Supplement Dates Manufacturer Received: 08/14/2023; 09/26/2023
• Supplement Dates FDA Received: 08/21/2023; 09/27/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Life Threatening
• Patient Sex: Prefer Not To Disclose