MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT-3D-AV; COILS

Model Number MV-00306HHTA

Device Problem Component Missing (2306)

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

Event Date 07/26/2023

Event Type  malfunction  

Event Description

It was reported after the electrical continuity check, the coil was inserted into the microcatheter without checking of the implant.During advancement resistance was encountered, and the coil delivery system was withdrawn immediately and checked.Upon removal it was observed that the coil was missing, and no implant coil was found in the microcatheter or the surrounding area.The coil was replaced with another coil, and the procedure was successfully completed.There was no patient harm reported.

Manufacturer Narrative

A search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was discarded at the user facility and not returned to the manufacturer for evaluation.Procedural or medical imaging was not provided.Without the return and physical evaluation of the device, the investigation is unable to determine if a condition existed that would have caused or contributed to the reported event.The event as described could not be confirmed.If additional information is received at a later date, a supplemental mdr will be submitted.

Event Description

No additional information was received.Please see h6 and h10.

Manufacturer Narrative

Items returned: n/a visual analysis: a visual inspection of the device captured in this file could not be performed as a physical device was not returned for evaluation, nor were any images of the device provided in place of a device return.Procedure and medical imaging was not provided for this investigation.Investigation findings: without the return and physical evaluation of the device, the investigation cannot definitively determine if a condition existed that would have caused or contributed to the reported event.Without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.Based on a review of the device's risk documentation, the reported event did not indicate there were any potential or new manufacturing, design, quality, or other systemic issues, or non-conformances.The complaint code is monitored through the trending process; corrective action is determined, as needed, through this process.Investigations of historic complaint files with similar complaint category coding are recorded in the complaint handling system; without the ability to perform and analysis of the device, this investigation cannot identify with certainty any potential root causes.Batch review: a search for non-conformances associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.Complaint system review: there are no similar complaints based on the complaint category regarding this batch number from the last two years recorded in the complaint system at the time of this investigation.Ifu review (additional information can be found in the ifu): potential complications potential complications include, but are not limited.Verify to take care of this matter before do procedure.[serious complications] hematoma at the site of entry vessel perforation aneurysm rupture parent artery occlusion incomplete aneurysm filling emboli, hemorrhage, ischemia, vasospasm clot formation revascularization syndrome, and neurological deficits including stroke and possibly death.With this use of this product, potential malfunctions may occur, but are not limited.Verify to take care of this matter before do procedue.[serious malfunctions] coil migration or misplacement, premature or difficult coil detachment warnings and precautions manipulate the delivery pusher carefully.Do not advance it with excessive force.Determine the cause of any unusual resistance during operation.[otherwise, the hes may become damaged or break.] take care not to kink the delivery pusher while handling the hes.Stop using the deliver pusher if it has kinked.[the use of a kinked delivery pusher could cause damage or breakage to the hes.] do not apply excessive bending/loading or torque to the delivery pusher while handling the hes.[applying such force may cause the lead wire to be detached or break.] prior to using the hes, remove the coil from the introducer sheath to inspect the coil portion for any irregularities, such as a break, kink, stretch or detachment.[the use of a damaged coil could cause an unexpected event, such as blood vessel injury, during coil placement or detachment.] the hes should not be immersed in any organic solvent-containing agent, such as alcohol for disinfection, or wiped with any agent.[the hes may become damaged, cracked, or less lubricant.] preparation of the hes for delivery remove the detachment controller from the package.The detachment controller is separately packed as a sterile device.Pull the white pull-tab from the side of the detachment controller.Discard the pull-tab and place the detachment controller in the sterile field.Wait three seconds and observe the indicator light on the detachment controller.Note - if the green light does not appear or if a red light appears, replace the device.- if the light turns green, then turns off at any time during the three-second observation, replace the device.- if the green light remains solid green for the entire three-second observation, continue using the device.Hold the hes just distal to the shrink-lock and pull the shrink-lock proximally to expose the tab on introducer sheath (figure 1).Slowly advance the hes implant out of the introducer sheath and inspect the entire delivery pusher, the coil, and the distal end of the delivery pusher for any irregularities, such as a break, kink, stretch or coil detachment.Note - if any damage is observed, replace the hes with a new one.- the use of a damaged coil may injure the vessel or cause an unexpected reaction of the coil during coil placement or detachment.While holding the introducer sheath vertically, gently and carefully retract the coil back into the introducer sheath about 1 to 2 cm from its distal end.Note - the coil must be gently retracted.Otherwise, it may become stretched, tangled, damaged or break.Investigation conclusion the physical device was not available for evaluation to determine if a condition existed that would have caused or contributed to event.Supplemental imaging was also unavailable for review; without imaging, the investigation cannot verify the event occurred as described, nor could the investigation definitively determine the cause of the reported event.This information may be updated if additional information is provided at a later date.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• Manufacturer Contact: terrence callahan ; 35 enterprise drive; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17510321
• MDR Text Key: 321163868
• Report Number: 2032493-2023-00894
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 04987350006691
• UDI-Public: (01)04987350006691(11)221003(17)270930(10)0000267712
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161367
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MV-00306HHTA
• Device Lot Number: 0000267712
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/03/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1