MAUDE Adverse Event Report: ACCURATE MEDICAL THERAPEUTICS LTD. MICROCATHETER SEQURE 28 130 X1

Model Number SQ28_LB_130

Device Problems Break (1069); Retraction Problem (1536); Material Protrusion/Extrusion (2979)

Patient Problem Rupture (2208)

Event Date 03/23/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to the manufacturer for evaluation and therefore the exact cause could not be determined.In addition, the lot number was not provided, and non-conformances associated with this lot could not be investigated.During the manufacturer's investigation, it became known that the physician requested a drakon 2.8 fr microcatheter (accurate medical therapeutics) for embolization but was mistakenly given a sequre 2.8 fr catheter instead of the requested drakon 2.8fr.Therefore, throughout the procedure, the physician was unaware that the microcatheter being used has side slits on the catheter distal end.The finding that the physician was not aware that the catheter being used was sequre may have contributed to this event.It is the manufacturer's assumption that the interpretation that a microcatheter breakdown occurred likely reflects slit distortion.Irrespectively, some level of damage to the patient vessel occurred.The difficulty of microcatheter retrieval through the guide catheter is likely due to this same slit distortion.In accordance with ifu, the physician removed the microcatheter together with the guiding catheter once resistance was felt with no additional difficulties.Although the definite cause cannot fully be determined, a high internal pressure during power injection has likely caused the catheter damage.Importantly, the procedure was completed successfully, and the patient was reported with no clinical sequel post procedure and no additional patient complications were reported.

Event Description

This incident was reported by attending physician on (b)(6) 2019.During a trauma embolization procedure of a pseudo aneurysm in a patient with liver laceration stage 4 tumor, the physician had thought he experienced a physical breakdown of the distal tip of the microcatheter occurred with no disconnecting parts.The damage to the microcatheter occurred after the vessel was embolized successfully with the pva particles during power injection as detailed below.Following the embolization, the microcatheter was flushed with saline until no contrast media was seen exiting the catheter distal end and then a few manual injections of contrast media were done.Following those injections, a power injection was performed a little bit proximal to the embolization.During this power injection, the catheter seemed to have some physical breakdown and contrast media was seen exiting through the side of the catheter and damaging the patient's vessel.An attempt to pull out the microcatheter failed and eventually it was removed with the 5fr guide catheter.Upon removal, the microcatheter seemed to be damaged at the distal section with unidentified red staining material sticking out from the catheter side with no disconnected parts.Although the patient had a hepatic artery segment 6 rupture, there was no need for remedial action to be taken as no real harm was caused to the patient.

• Brand Name: MICROCATHETER SEQURE 28 130 X1
• Type of Device: MICROCATHETER SEQURE 28 130 X1
• Manufacturer (Section D): ACCURATE MEDICAL THERAPEUTICS LTD.; 21 habarzel street; tel-aviv, 69710 29; IS 6971029
• Manufacturer Contact: orly maor ; 25a sirkin street; kfar saba, 44421 ; IS 44421
• MDR Report Key: 9986770
• MDR Text Key: 192039168
• Report Number: 3011890588-2020-00001
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SQ28_LB_130
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1