MAUDE Adverse Event Report: ACCURATE MEDICAL THERAPEUTICS LTD. MICROCATHETER SEQURE 28 150 X1

Model Number SQ28_LB_150

Device Problem Break (1069)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 03/06/2024

Event Type  malfunction  

Manufacturer Narrative

This manufacturer's preliminary investigation was conducted prior to receiving the used device for investigation and is based on the incident description by the user, the angiographic images that were sent, the examination of the lot history record of the involved device, and the manufacturer's assumptions.The sequre microcatheter was used for the injection of embozene microspheres and then contour pva particles, during a uterine fibroid embolization procedure.During the procedure, a small arterial vasospasm was realized.Verapamil was injected to counter the spasm and no clinical sequel regarding the vasospasm was mentioned.The physician noticed the clogging following the flushing of the microcatheter with saline.It is assumed that the clogging inside the microcatheter was a result of the injection of the pva particles since they were used after the embozene microspheres and pva particles are known to have a higher clogging rate than other embolization materials.From the angiographic images, it seems that the microcatheter was already kinked/distorted at this point.It is possible that the kink/distortion resulted from flushing of the catheter with saline which caused an internal high pressure and possible distortion of the sequre side slits.Thereafter, when the physician tried to open the blockage by inserting the guidewire he felt the resistance was relieved but then noticed on the angiographic imaging that the distal end (seems to be from the kinked/distorted area) of the sequre 2.8fr-150cm microcatheter had broken off.Importantly, the physician managed to retrieve the broken tip using another microcatheter as a guiding catheter for a snare.There were no remaining foreign objects in the patient and the procedure was completed successfully with no known clinical sequel to the patient.The device lot history record (lhr) from production was reviewed with no unusual findings that may have led to any malfunction of the device.Blockages of microcatheters during embolization are a known and well-defined risk and pva particles are known to have a higher clogging rate than other embolization materials.This is most likely due to particulate aggregation, making the effective size of the pva particles larger than their actual size.Importantly, the adverse event that occurred relates to the events following the clogging.Once blockages occur, it is recommended to remove the microcatheter in full from the patient.Therefore, the sequre ifu, includes warnings not to use excessive force when advancing a guidewire through a kinked/blocked microcatheter and to replace the device with a new one if resistance is felt during injection, in order to avoid potential vessel damage/injury.Conclusion: the manufacturer's preliminary investigation finds that the detachment of the distal region of the sequre catheter was a result of additional events which occurred during the procedure after the clogging of the device.Initially, the catheter clogged during embolization with pva particles.It should be noted that clogging of microcatheters is a known event and should it occur, removal of a clogged catheter without further manipulation would result in procedural delay.Since further manipulation of the kinked/distorted catheter was performed in order to open the blockage with guidewire, mechanical damage to the microcatheter occurred including detachment of the distal end.Finally, the procedure was completed, and no immediate complications were noticed, and no untoward clinical findings were reported by the user.

Event Description

This case was reported by a facility in (b)(6) on 06 march 2024.Facility reports that sequre 2.8fr-150cm microcatheter normal pre-procedure preparation done.Microcatheter flushed with saline.Advanced guidewire without resistance.Started embolization with embozenes (250 microns and then 400 microns).Contour particles (355 -500) mixed with contrast media (imeron 300) and saline.Approximately 10ml imeron injected at a 80/20 dilution with saline.No event observed at this stage.Sequre 2.8fr-150cm microcatheter was still inserted inside the patient when a small arterial vasospasm was realised (injected 0.25 mg verapamil intra-arterially to counter the spasm).Procedure was almost done when the doctor decided to inject more contour particles.Sequre 2.8fr-150cm microcatheter was flushed inside of the patient with saline and met with resistance.Doctor asked for a guidewire to advance and open the blockage.Doctor thought the guidewire had advanced as the resistance was relieved.Saw on imaging that the tip of the sequre 2.8fr-150cm microcatheter had broken off.At this stage, everything was removed.Preparation for a prograde catheter and injected contour particles (300-550) without issue.6ml imeron 300 / saline mix with contour particles.Used prograde catheter as a guiding catheter for a snare.Snare of sequre 2.8fr-150cm microcatheter done easily.Aortogram done to ensure no obstruction or remaining foreign bodies - normal.Images attached pre and post intervention to remove sequre 2.8fr-150cm tip.Procedure was completed.Patient was under general anaesthetic throughout.

• Brand Name: MICROCATHETER SEQURE 28 150 X1
• Type of Device: MICROCATHETER SEQURE 28 150 X1
• Manufacturer (Section D): ACCURATE MEDICAL THERAPEUTICS LTD.; 19 eli hurvitz street; rehovot, 76088 02; IS 7608802
• Manufacturer Contact: ofir levit ; 19 eli hurvitz st.; rehovot, 76088-02 ; IS 7608802
• MDR Report Key: 18959258
• MDR Text Key: 339327712
• Report Number: 3011890588-2024-00001
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 07290017268088
• UDI-Public: 01072900172680881725033010344055
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K173430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SQ28_LB_150
• Device Catalogue Number: 234055
• Device Lot Number: 344055
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/31/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 32 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White