MAUDE Adverse Event Report: MICROCATHETER SEQURE 28 130 X1

Model Number SQ28_LB_130

Device Problem Flushing Problem (1252)

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

Event Type  malfunction  

Manufacturer Narrative

As this case was related to user error, there is no plan to perform an investigation on the device.

Event Description

This incident was reported by a facility in (b)(6) on (b)(6) 2020 without sufficient information to process an mdr.Follow-up information, sufficient for processing, was received from reporter on 14 january 2021.Reporter states that the sequre catheter was used for angiomyolipoma embolization.Embolization was done with two types of agents: 700 um microspheres for a 2ml in 20ml dilution.A berenshtein liquid coil was added subsequently.The coil remained blocked in the sequre.The interventional radiologist was unable to flush the sequre.The radiologist then changed the microcatheter to complete the embolization, stating that there was no injury to the patient.

Event Description

This incident was reported by a facility in marseille, france on (b)(6) 2020 without sufficient information to process an mdr.Follow-up information, sufficient for processing, was received from reporter on (b)(6) 2021.This supplemental report is to document the change in reportability, to non-reportable.On (b)(6) 2020 a guerbet commercial engineer (ce) notified to the quality department by email a complaint regarding one sequre catheter clogging at chu marseille 13000 marseille.The ce was initially informed on (b)(6) 2020.The catheter was used for angiomyolipoma embolization.Embolization was done with two types of agents: 700m microspheres for a 2ml in 20ml dilution.A berenshtein liquid coil was added subsequently.The coil remained blocked in the sequre.The interventional radiologist was unable to flush the sequre.Additional information were requested to our ic (serial number, diameter of the sequre catheter, size of coils, details on the procedure, possible catheter replacement, procedure completed, consequences for the patient, etc.).

Manufacturer Narrative

Manufacturer: new information that was received indicating what type of coil was used : flushable coils, spif 2.5mm x10cm from balt, which is a 0.010" coil, and therefore off label for our microcatheters, as they are compatible only with 0.018" coils.As this was a user-error/deviation from label use, this incident was investigated at the manufacturer site, potential risk to the patient was assessed minor (via product risk analysis), and assessment has been changed to non-reportable.

• Brand Name: MICROCATHETER SEQURE 28 130 X1
• Type of Device: MICROCATHETER SEQURE 28 130 X1
• MDR Report Key: 11197984
• MDR Text Key: 244239035
• Report Number: 3011890588-2021-00001
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• PMA/PMN Number: K173430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SQ28_LB_130
• Date Manufacturer Received: 01/14/2021
• 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