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

Model Number	BEQ-PAL 1723-USA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Codes	Failure of Implant (1924); Perforation of Vessels (2135)
Date of Event	11/01/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while putting a patient on a hls support, an hls cannulae was introduced to right femoral artery, after insertion wire was removed however during the removal of introducer handle was broke and therefore a recannulation was required.The patient had to go back to the operating room for proper closure of the right fma and vascular repair.Prior to hls support patient had chest compressions and hemoperitoneum which exasperated the situation.Patient harm was explained as due primarily due to patient condition at time of procedure.Since the event was occurred during treatment / on patient use and the product change was required, the complaint is reportable.Complaint # (b)(4).
Additional Manufacturer Narrative
A follow-up medwatch will be submitted when further information becomes available.
Event or Problem Description
Complaint #: (b)(4).
Additional Manufacturer Narrative
Further information has been received on (b)(6) 2025 which states that holes were observed on patient's artery that might have caused by the reported product failure.A follow-up medwatch will be submitted when further information becomes available.
Event or Problem Description
Complaint # (b)(4).
Additional Manufacturer Narrative
Further information has been received on 2025-11-19 which states that patient demographics is female in 60¿s.A follow-up medwatch will be submitted when further information becomes available.
Event or Problem Description
Complaint # (b)(4).
Additional Manufacturer Narrative
The production history record (dhr) of the affected beq-pal 1723-usa with lot# 3000465146 was reviewed on 2025-11-25.According to the dhr result, the product beq-pal 1723-usa passed the defined manufacturing and final release specifications.A follow-up medwatch will be submitted when further information becomes available.
Additional Manufacturer Narrative
It was reported that while putting a female patient in her 60s on a hls support, an hls cannulae was introduced to right femoral artery, after insertion wire was removed however during the removal of introducer handle was broke and therefore a recannulation was required.The patient had to go back to the or for proper closure of the right fma and vascular repair.Prior to hls support patient had chest compressions and hemoperitoneum which exasperated the situation.Patient harm was explained as due primarily due to patient condition at time of procedure.Further information received which states that holes were observed on patient's artery that might have caused by the reported product failure.The product was investigated at the maquet cardiopulmonary gmbh laboratory on (b)(6) 2026.The laboratory investigation of the returned handle revealed an inhomogeneous glue distribution inside the gluing area, with only minimal glue residues visible under uv light.No cracks, fractures, impact marks, or deformations were observed.As only the handle was returned, a full component-level evaluation was not possible.However, based on the observed condition, the most probable root cause for the separation between handle and introducer shaft was identified as a manufacturing-related bonding deficiency at the glued interface.Getinge medical affairs conducted a medical review: based on the information available from the complaint documentation, clinical questionnaire, and returned-product investigation, the reported event was confirmed.The introducer handle was identified as detached from the introducer shaft.No evidence was identified during the laboratory investigation that indicates a use error.According to the clinical questionnaire, the device had been inspected prior to use with intact packaging.The introducer was inserted into the cannula without difficulty or resistance being encountered.The separation of the handle occurred during the customary step of dilator removal after cannulation insertion.The patient was described as hemodynamically decompensating, which required chest compressions to be performed prior to cannulation.The patient was also described as having a hemoperitoneum.The reported device behavior represents a malfunction (as described by the product investigation) that manifested as the introducer handle detaching from the introducer shaft.The detachment did not allow completion of the seldinger procedure.According to the complaint narrative, the reported malfunction was associated with re-cannulation of the left femoral artery and subsequent vascular repair of the right femoral artery.Based on the available information, the hazardous situation involved the unintended detachment of the introducer handle during removal, resulting in the inability to separate the introducer from the cannula.The event required the simultaneous extraction of both components from the right femoral location.It is possible that the reported malfunction contributed to vascular injury requiring surgical intervention.The origin of the vascular damage was not explained in full; however, it is possible that the reported vascular injury that necessitated operative repair may have been associated with disconnection of the introducer handle.That said, it is unknown if other factors may have been contributory considering the emergent nature of the case and the application of chest compressions.Below warnings were included in the ifu of the product: warning! damage to the device or packaging.A non-sterile or defective device can result in patient infections.- perform a careful visual inspection of the sterile packaging before use.Pay particular attention to moisture, openings and soiling.- perform a careful visual inspection of the device before use.In particular, ensure there is no damage to the material, cracks, burrs or fissures.The hls cannula can be introduced either into the previously exposed vessel under visual control 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.Caution! if necessary, dampen the introducer with sterile saline solution prior to insertion into the cannula.Caution! check that the introducer can be moved freely before the cannula is used.It must be possible to move the introducer freely and without hindrance.Caution! ensure that the tip of the introducer protrudes from the tip of the cannula and that there is no gap between the cannula and the introducer.Caution! if you use the arterial cannula, check the luer lock caps are secure before use.Caution! the vessel must be sufficiently large to ensure perfusion and venous return flow.- insert the introducer into the cannula and secure it in the cap of the cannula.The handle of the introducer must engage in the cap and thus be locked in place.Caution! only use the cannula with an introducer along a guide wire with a diameter of 0.97 mm (0.038").- slide the cannula with pre-mounted introducer along the guide wire as far as the puncture site.Caution! do not insert the cannula too far into the vessel.Warning! use the depth marks to position the cannula in the desired location within the aorta.Placement of the cannula too distally in the ascending aorta and aortic arch can lead to cerebral hypoperfusion, severe ischemic injury, and/or death.Caution! the guide wire must not be advanced further into the vessel while inserting the cannula.Caution! if increased resistance is felt during insertion, pull the cannula back and search for the cause with the aid of the appropriate imaging.Caution! verify the advancement and positioning of the guide wire using appropriate imaging technology.- insert the tip of the introducer carefully 3 to 5 cm into the vessel.Grip and secure the guide wire until the cannula has been advanced into the desired position.A gentle turning movement while advancing the cannula facilitates the procedure.Caution! the cannula must not be displaced from the correct position whilst the guide wire is being removed.- remove the guide wire.Caution! only remove the introducer once the guide wire has been removed.Caution! do not clamp the cannula when the introducer is in the cannula.Caution! in order to prevent any blood loss through the cap, pull the introducer back in the axial direction initially just as far as the distal depth marking.Clamp the cannula at the point provided for this purpose before completely removing the introducer.- remove the introducer from the cannula and clamp the cannula at the point provided for this purpose.Please observe the clamping symbol.A follow-up medwatch will be submitted when further information becomes available.Based on the investigation results, the most probable cause was found as related with lack of glue application - manufacturing.A non-conformity record #3057578 has been initiated in scope of this specific complaint on (b)(6) 2026.All further actions will be taken within this non-conformity record.Since the most probable cause has been found as a production related failure, and all further investigation will be performed within nc #3057578, a dhr review is not feasable.The review of scrap, rework, enhancements and design changes were performed an no abnormalities was found in regard to the reported failure.In addition, a review for potential field actions and capas related to the failure and product in this complaint was performed.This complaint is not in scope of any ongoing field actions and/or capas.Based on the investigation results, complaint could be confirmed.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 or Problem Description
Complaint #(b)(4).

• Brand Name: HLS CANNULA + PIK
• Common Device Name: 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: 23476444
• Report Number: 8010762-2025-0000490
• Device Sequence Number: 21389553
• Product Code: DWF
• UDI-Device Identifier: 04037691750316
• UDI-Public: (01)04037691750316(11)250321(17)270321(10)3000465146(240)701053082
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K102532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 01/28/2026

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
• Operator of Device: Health Professional
• Device Model Number: BEQ-PAL 1723-USA
• Device Catalogue Number: 701053082
• Device Lot Number: 3000465146
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2025
• Supplement Date Received by Manufacturer: 11/10/2025; 11/19/2025; 11/25/2025; 01/21/2026
• Initial Report FDA Received Date: 11/05/2025
• Supplement Report FDA Received Date: 11/19/2025; 11/25/2025; 12/04/2025; 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 60 YR
• Patient Sex: Female