MAUDE Adverse Event Report: ACCURATE MEDICAL THERAPEUTICS LTD. MICROCATHETER SEQURE 24 150 X1

Model Number SQ24_MB_150

Device Problem Obstruction of Flow (2423)

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

Event Date 10/23/2022

Event Type  malfunction  

Event Description

This incident was reported by a facility in greece on 24 october 2022.The reporter states that an interventional radiologist reported a patient of unknown gender, age and medical history, underwent procedure with sequre microcatheter on (b)(6) 2022.After catheterizing a bronchial artery with a 5 fr simon catheter, insertion the sequre microcatheter to obtain a more distal position and perform embolization with contour particles (boston scientific) 250-355 um.During embolization the microcatheter clogged.Physician tried to unblock it by injecting water with a 1cc syringe.This was unsuccessful so tried to insert the microwire into the microcatheter (asahi 0.016').Noticed that the microwire appeared on the screen at the side of the microcatheter meaning that it exited the microcathered proximally from the end- hole, denoting that there was a fracture of the microcatheter.Tried to take the microcatheter out but it wouldn't come.It appeared as if it were stuck on the simon catheter.Considered taking everything out, but there was the risk of losing a microcatheter segment somewhere in the vasculature.Decided to pull only the microcatheter hoping to lose only the distal segment that was fully inside the bronchial artery that we intended to embolize.And hopefully, that was the case.Afterwards, catheterized a second bronchial artery with a 5 fr cobra catheter and insertion another sequre microcatheter.The same problem occurred again, only this time the microcatheter came all out without losing a segment.On inspection, it appeared that the microcatheter was kinked/partially fractured at the region of its proximal side holes, finally inserted a third, different type of microcatheter and concluded the procedure.The reporter states that the patient was connected, procedure was completed, no reported adverse events.Follow-up information received on 27 october 2022 by the interventional radiologist: this case refers to a male patient 58 years old."due to the catheter clogging and malfunction we lost access to the vessel.But we were able to regain access afterwards.No immediate complications were noticed.Catheter rupture is a significant risk because the segment might be lost in the vascular system, embolize and cause ischemic complications.And also, particles might be lost from the proximal part of the fragment in the bronchial artery giving rise to non target embolization to more proximal vascular branches.No sample or catheter pictures are available.

Manufacturer Narrative

Preliminary results and conclusions of manufacturer's investigation the manufacturer did not receive the used device for investigation, therefore, the initial investigation is based only on the incident description by the user and the manufactures assumptions.The sequre microcatheter clogged when using pva particles during a bronchial artery embolization.This is a known occurrence that may occur with pva particles as they are known to cause clogging of microcatheters.When the microcatheter clogged, the physician tried to open the clogging by injection of water with a 1cc syringe which could result in a high pressure injection.It is assumed that this internal high pressure probably caused a distortion of the sequre side slits.When the physician tried to open the clog with by inserting the guidewire he saw it exiting from the side of the catheter, probably through the distorted slits.Blockages of microcatheters during embolization are a known and well defined risk and therefore the sequre ifu, includes the following warning - "if an increase of resistance is felt when injecting fluid through the microcatheter, replace the microcatheter with a new one.Injection against increased resistance may cause the microcatheter to rupture, potentially injuring the blood vessel.".In addition, the following caution is given in the ifu too - "increased resistance to infusion suggests that the microcatheter may be blocked by the drug or contrast media being infused or with blood clots.Immediately terminate the infusion and replace the microcatheter.".When the physician tried to pull back the device through the guiding catheter, it was stuck.The manufactures assumption is that there was a bump at the distal tip of the microcatheter due to the clogging of the microcatheter by the pva particles and the forceful water injection that caused a distortion of the slits and a possible bump in that area.This potentially led to an enlargement of the catheter outer diameter and due to that enlargement, the microcatheter's outer diameter may have been larger than the guiding catheter inner diameter and therefore it could not re-enter through its distal end.The physician decided not to pull back the microcatheter with the guiding catheter so not to risk detachment of the microcatheter tip or introducing particles into proximal vessels and decided to pull forcefully the microcatheter in its location - the bronchial artery which was already partially embolized.When the sequre microcatheter was pulled back forcefully, the tip probably detached from the device as it could not enter the guiding catheter, and it remained in the bronchial artery.A second sequre microcatheter was inserted in an attempt to complete the embolization of the bronchial artery and clogged too.This second microcatheter was withdrawn without any reported damage.Eventually the procedure was completed successfully with an additional microcatheter that completed the embolization of the bronchial artery.Importantly, no immediate complications were noticed and no untoward clinical findings were reported by the user.Description of the manufacturer's evaluation concerning possible root causes/causative factors and conclusion.The detachment of the tip was a result of several events which occurred during the procedure.Initially the catheter clogged during embolization with pva particles.Clogging of microcatheters is a known event and the adverse event that occured relates to the events following the clogging.Removal of a clogged catheter without further manipulation is expected to result in procedural delay.When the catheter clogged, the physician tried to forcefully open the clogging using injection of water that probably caused a distortion of the slits and possibly also a bump in that area.When the physician tried to open the clog with by inserting the guidewire he saw it exiting from the side of the catheter, probably through the distorted slits.These events probably led to an enlargement of the catheter outer diameter and due to that enlargement, the microcatheter's outer diameter was larger than the guiding catheter inner diameter and could not re-enter through its distal end.When the microcatheter was pulled back forcefully, the tip probably detached from the device as it could not enter the guiding catheter, and it remained in the bronchial artery.In addition, the device lot history record from production was reviewed with no unusual findings that may have led to any malfunction.Two previous customer complaints of devices from this lot were identified and were concluded to be unrelated to this event.In conclusion, the clogging, followed by forceful water injection, caused an enlargement of the microcatheter's tip which could then not be pulled back through the guiding catheter.The forceful pullback of the microcatheter through the guiding catheter caused the tip to detach.

Event Description

This incident was reported by a facility in greece on (b)(6) 2022.The reporter states that an interventional radiologist reported a patient of unknown gender, age and medical history, underwent procedure with sequre microcatheter on (b)(6) 2022.After catheterizing a bronchial artery with a 5 fr simon catheter, insertion the sequre microcatheter to obtain a more distal position and perform embolization with contour particles (boston scientific) 250-355 um.During embolization the microcatheter clogged.Physician tried to unblock it by injecting water with a 1cc syringe.This was unsuccessful so tried to insert the microwire into the microcatheter (asahi 0.016').Noticed that the microwire appeared on the screen at the side of the microcatheter meaning that it exited the microcathered proximally from the end- hole, denoting that there was a fracture of the microcatheter.Tried to take the microcatheter out but it wouldn't come.It appeared as if it were stuck on the simon catheter.Considered taking everything out, but there was the risk of losing a microcatheter segment somewhere in the vasculature.Decided to pull only the microcatheter hoping to lose only the distal segment that was fully inside the bronchial artery that we intended to embolize.And hopefully, that was the case.Afterwards, catheterized a second bronchial artery with a 5 fr cobra catheter and insertion another sequre microcatheter.The same problem occurred again, only this time the microcatheter came all out without losing a segment.On inspection, it appeared that the microcatheter was kinked/partially fractured at the region of its proximal side holes, finally inserted a third, different type of microcatheter and concluded the procedure.The reporter states that the patient was connected, procedure was completed, no reported adverse events.Follow-up information received on 27 october 2022 by the interventional radiologist: this case refers to a male patient 58 years old."due to the catheter clogging and malfunction we lost access to the vessel.But we were able to regain access afterwards.No immediate complications were noticed.Catheter rupture is a significant risk because the segment might be lost in the vascular system, embolize and cause ischemic complications.And also, particles might be lost from the proximal part of the fragment in the bronchial artery giving rise to non target embolization to more proximal vascular branches.No sample or catheter pictures are available.

• Brand Name: MICROCATHETER SEQURE 24 150 X1
• Type of Device: MICROCATHETER SEQURE 24 150 X1
• Manufacturer (Section D): ACCURATE MEDICAL THERAPEUTICS LTD.; 19 eli hurvitz street; rehovot, 76088 02; IS 7608802
• Manufacturer Contact: gabriel lebovic ; 214 carnegie center, suite 300; princeton, NJ 08540 ; 2153804933
• MDR Report Key: 15824765
• MDR Text Key: 308002518
• Report Number: 3011890588-2022-00005
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: K173430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 10/24/2022

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: 10/30/2022
• Device Model Number: SQ24_MB_150
• Device Lot Number: 530109B
• Initial Date Manufacturer Received: 10/24/2022
• Initial Date FDA Received: 11/18/2022
• Supplement Dates Manufacturer Received: 10/24/2022
• Supplement Dates FDA Received: 01/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Sex: Male