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

Model Number AVALON ELITE CANNULA & CATHETER

Device Problem Improper or Incorrect Procedure or Method (2017)

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

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 the us.It was reported that during a call with a customer about new products, the customer mentioned that during insertion of an avalon elite cannula, a perforation of the surrounding vascular structure occurred in 2021.The customer mentioned that the product did not appear to be the root cause of the event.The customer attributed the event to extenuating circumstances and, possibly, insertion technique.The customer mentioned that the date of the event is not known exactly, but that the event occurred sometime in 2021, possibly 6 months ago.No other details were disclosed or conveyed by the customer in a follow up conversation after the for mentioned product call.The manufacturer requested information about the event and the consequences to the patient but still pending.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that during a call with a customer about new products, the customer mentioned that during insertion of an avalon elite® bi-caval dual lumen cannula, a perforation of the surrounding vascular structure occurred in 2021.The customer mentioned that the product did not appear to be the root cause of the event.The customer attributed the event to extenuating circumstances and, possibly, insertion technique.The customer mentioned that the date of the event is not known exactly, but that the event occurred sometime in 2021, possibly 6 months ago.No other details were disclosed or conveyed by the customer in a follow up conversation after the for mentioned product call.The customer was not submitting a complaint at the time of event since he did not report a malfunction of the product.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.The reported event and the application method described by the customer was evaluated by getinge medical affairs on 2022-04-25 with the following outcome: during a conference call that was arranged by getinge marketing to discuss current and potential products, the customer mentioned that his institution experienced a perforation while inserting the avalon elite® bi-caval dual lumen cannula.In a follow up conversation with the customer after the conference call, it was disclosed that during insertion of the avalon elite® bi-caval dual lumen cannula that a perforation of the surrounding structures was described.The customer stated that the perforation was not caused by the product, per se, but was the result of the combination of the insertion technique and the ¿extenuating circumstances¿ of the insertion.No details were divulged on the insertion technique involved or the ¿extenuating circumstances¿ surrounding the insertion.Except for the approximate age of the patient (i.E.14-15 years old), no further information was disclosed regarding the status of the patient, associated comorbidities, or details regarding post-procedure/post-therapy outcomes.It is assumed that the intention was to support the patient using a veno-venous venue, as the avalon elite® bi-caval dual lumen cannula was the cannula of choice.Finally, the customer was clearly reluctant to share further details of the event despite three good faith attempts (via email) and one phone call with the customer to gain more details of the event.Conclusion: given the sparse details involved in this complaint, in addition to the statement from the customer stating that the avalon elite® bi-caval dual lumen cannula was not necessarily the precipitating culprit involved in the perforation, it is challenging to assign culpability to the product.As was mentioned in the previous section, the customer stated that the event described in this complaint steered more to ¿insertion technique¿ complicated with ¿extenuating circumstances¿, than a clear attribution to the product.Based on the information available at this time the cause of the reported event was determined to not be attributed to a device related malfunction.A review of the device history record (dhr) is not possible, as neither part number, nor lot number of the affected avalon elite® bi-caval dual lumen cannula is available.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 version 04 · us chapter 7 application 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.

Event Description

Complaint id: (b)(4).

• 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: 13977184
• MDR Text Key: 288469979
• Report Number: 8010762-2022-00108
• 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
• Report Date: 05/03/2022

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: AVALON ELITE CANNULA & CATHETER
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/22/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/25/2022
• Supplement Dates FDA Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 15 YR