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

Model Number MV-00306HHTA

Device Problems Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 06/28/2023

Event Type  malfunction  

Event Description

It was reported that during device preparation, the product in dispenser coil was placed in the tray filled with saline.The ink on the barcode label was reported to peel off.The coil was used without incident and the procedure was completed successfully.No patient harm or injury was reported.

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): please refer to the japanese ifu for precautions, warnings, and further information.The following is taken from the english version: preparation of the coil system for delivery remove the detachment controller from its protective packaging.The detachment controller is packaged separately as a sterile device.Flush the device in advance with heparinized saline solution by following the steps below.Remove the dispenser tube from the packaging.Flush the dispenser tube with a minimum of 3 ml of heparinized saline solution from the dispenser hub by syringe to thoroughly wet the distal surface of the device.Slowly remove the proximal end of the device from the dispenser tube.Caution·if excessive friction is noted during operation, flush again with heparinized saline solution and thoroughly wet the surface without forcing it out before removing it.Firmly insert the proximal end of the pusher catheter into the funnel section of the detachment controller.At this time, confirm that the buzzer of the detachment controller sounds and the green light stays on for 3 seconds, and then remove the proximal end of the pusher from the detachment controller.Caution·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.Slowly advance the coil out of the introducer sheath and inspect the coil for any irregularities or damage.Caution·if any damage to the coil or pusher catheter is observed, replace it to the new coil delivery system.If the damaged coil is used, it can damage blood vessels during coil placement/detachment and/or undesirable movement of the coil is observed with the distal end of the introducer sheath pointed downward, gently retract the implant back completely into the introducer sheath about 1 to 2 cm.Caution·if not retract slowly, the coil may stretch, knot, damage or break.The device was not returned to the manufacturer for analysis.If the device or additional information is received, microvention, inc., will submit a supplemental mdr report.

Manufacturer Narrative

A correction, supplemental-1 report is being submitted or correct the medical device problem code from 2933 to 1670.The code was chosen in error.It was reported that during device preparation, the product in dispenser coil was placed in the tray filled with saline.The ink on the barcode label was reported to peel off.The coil was used without incident and the procedure was completed successfully.No patient harm or injury was reported.

• Brand Name: HYDROSOFT-3D-AV
• Type of Device: COILS
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise; aliso viejo CA 93446
• Manufacturer Contact: terrence callahan ; 35 enterprise; 35 enterprise; aliso viejo, CA 92656 ; 7142478000
• MDR Report Key: 17283856
• MDR Text Key: 318833231
• Report Number: 2032493-2023-00833
• Device Sequence Number: 1
• Product Code: HCG
• 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,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• 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: 0000283588
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2022
• 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
• Patient Outcome(s): Other