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

Model Number BE-PAS 1715#BE-HLS CANNULA 17F AS

Device Problem Difficult to Insert (1316)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when further information becomes available.

Event Description

It was reported arter dissection was occurred during the placement of the maquet 17fr 15cm cannula.It was reported that it was impossibility of placing this same cannula in the left femoral artery.The user opened and used another 17fr maquet cannula 15cm.No clinical consequences were reported.No harm or death was reported.Complaint#:(b)(4).

Event Description

Complaint: (b)(4).

Manufacturer Narrative

A follow up medwatch will be submitted when further information becomes available.The laboratory investigation is completed on 2022-01-25.There could not be found any deformation that could cause to reported issue.The probable root cause could not be determined in laboratory investigation.Medical assessment is initiated, conclusion is pending for more information.

Event Description

Complaint: #(b)(4).

Manufacturer Narrative

It was reported that arter dissection was occurred during the placement of the maquet 17fr 15cm cannula.It was reported that there was impossibility of placing the same cannula in the left femoral artery.The user opened and used another 17fr maquet cannula 15cm.No clinical consequences were reported for arter dissection.Patient expired due to aort dissection.Customer states that there is no link between the product hls cannula and death.The product was not used on aort.The product was investigated in getinge laboratory.The fitting of the introducer into the cannula could be performed without any difficulties.Visual control of the cannula and fitting was not showing any deformations which could have lead to the reported failure.The production history record (dhr) of the affected be-hls cannula 17f as with lot# 3000161722 was reviewed on 2021-12-16.According to the dhr results, the product be-hls cannula 17f as passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.A medical assessment was performed by getinge medical affairs on 2022-02-22 as follows: femoral vascular access site complications and surgical mishaps are reported as a significant cause of morbidity and mortality.Cannulation complications are cited in the literature, are include as part of formal medical training, and have been considered as part of the risk management file for this product by getinge.The instructions for use for the hls cannula has multiple contraindications, and associated cautions and warnings are included: the presentation of emergent aortic dissection is associated with a spectrum of morbidity and mortality.There is no question that this was a very challenging clinical scenario that frequently presents with multiple co-morbidities that include peripheral atherosclerosis, and tortuous, friable target vessels.Despite expert care and due diligence, femoral arterial dissection during cannulation has been reported as a complication with an incidence rate of (b)(4)% (kalish, et al., 2015).In this instance, an hls cannula defect was ruled out as a root cause for the dissection.No defect was found on examination of the disposable.The use of femoral cannulation has associated risks as defined in the product risk file.These risks are represented in formal medical training, extensively reported in the literature, and are cited in the instructions for use.Application of the product, given the clinical risk profile, is at the discretion and best judgement of the physician, and is reliant on a patient-centric clinical risk benefit analysis.Last, because of the absence of available data on the involvement and/or extent of aortic dissection (e.G.Ct, tte, fluoroscopy with iv contrast, etc.), attributing the root-cause of the dissection to the cannula would be challenging.The cause of death was determined to be a result of acute and emergent aortic dissection and as customer states the product complaint had no association with the patient death.Based on the information provided and investigation results the failure could not be attributed to the device.The most probable root cause has been found as use complications or operational problems.The occurrence rate was calculated for the reported failure and product 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: 12766803
• MDR Text Key: 280452377
• Report Number: 8010762-2021-00584
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Remedial Action: Replace
• Type of Report: Initial,Followup,Followup
• Report Date: 03/11/2022

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 Expiration Date: 04/01/2023
• Device Model Number: BE-PAS 1715#BE-HLS CANNULA 17F AS
• Device Catalogue Number: 701047281
• Device Lot Number: 3000161722
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2021
• Initial Date FDA Received: 11/08/2021
• Supplement Dates Manufacturer Received: 01/25/2022; 02/22/2022
• Supplement Dates FDA Received: 02/18/2022; 03/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1