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

Model Number HLS CANNULA + PIK

Device Problem Break (1069)

Patient Problem Hematoma (1884)

Event Date 07/05/2021

Event Type  Injury  

Manufacturer Narrative

Investigation is still ongoing.A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that the guide wire (guide wire with j-tip in the percutaneous insertion kit (pik)) set was broken.The event took place during patient use.The piece of the guide was in the patient but was removed.No actual harm or death was reported.It was also reported by the customer that the venous puncture of the right internal jugular vein was done twice.The first time, guide had folded and ruptured inside the patient during the installation of the different dilators.The change of guide during the second puncture allowed the implementation of the cannula in good conditions.Then it was reported that there was hematoma at the puncture point of the right internal jugular vein.Complaint: # (b)(4).

Manufacturer Narrative

It was reported that the guidewire had bent and ruptured inside the patient during the placement of the various dilators.The change of guide during the second puncture of the right internal jugular finally allowed the placement of the 21fr reinjection cannula and the implementation of the v / a / v assistance under good conditions.A hematoma is subsequently noted at the puncture point of the right internal jugular vein.The product was received and investigated in the laboratory of manufacturer.The damaged guidewire was inspected more closely under the microscope.After approximately 70 cm the wire was bent more strongly and after approximately 20 cm the guide wire was found separated from the spring strand.Based on this failure could be confirmed.According to the investigation report, the guidewire has been deformed with a high mechanical force.The slightly deformed tip would confirm the complaint description for the rupture of the guidewire.Since the dilators are missing for the investigation no further observations or accurate root causes can be determined.Device history record for lot number 92311653 was reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.100% visual control was performed regarding guidewire kinks, shape errors per basic operation procedure 9204435 v00.100% visual control was performed regarding completeness and proper packaging into blister er basic operation procedure 9204437 v00.In addition, receiving inspection report of the reported fem guidewire_0.97x1000mm was reviewed and no non-conformity was detected with the material during incoming inspection.The medical review shows the available information and sequence of events suggests the guidewire may have been subjected to undue force, and/or resistance, during insertion that led to ¿doubling over¿ in the vessel.The doubling over of a guidewire may be associated with exceeding the force required for routine insertion and may be associated with fracture of the central support.Excessive force can exceed the tensile strength of the guidewire and cause the guidewire to fracture as reported.Based on the investigation results, the product related malfunctions can be excluded.The most probable cause could be detected as user interaction / use error.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.

Event Description

Complaint: # (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: 12158607
• MDR Text Key: 261229491
• Report Number: 3008355164-2021-00020
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K131666
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/08/2021

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?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS CANNULA + PIK
• Device Catalogue Number: 70104.7384
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/08/2021
• Distributor Facility Aware Date: 10/27/2021
• Event Location: Hospital
• Date Report to Manufacturer: 11/08/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/13/2021
• Supplement Dates Manufacturer Received: 10/27/2021
• Supplement Dates FDA Received: 11/08/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Sex: Prefer Not To Disclose