MAUDE Adverse Event Report: MICROVENTION, INC. HYDROSOFT 3D ADVANCED; EMBOLIZATION COIL

Model Number 7110-0310

Device Problems Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/07/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number was provided.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.A lot history trending review was performed and there were no similar complaints for this lot number.The device has been returned to the manufacturer.The investigation is underway.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

Event Description

It was reported that friction was encountered during the advancement of the 3rd coil in a subarachnoid hemorrhage anterior communicating artery aneurysm, and the coil got stuck inside the catheter.During removal, the coil detached in the catheter.There was no reported patient injury or intervention.The patient was reported to be doing well.

Manufacturer Narrative

The pusher, microcatheter, and implant were received for evaluation; a visual analysis revealed the implant was not attached to the pusher.The proximal hypotube of the pusher was bent.The distal body coil of the pusher was damaged.The heater coil of the pusher did not contain any indication of thermal damage.The microcatheter underwent x-ray examination.The implant was noted to be within the lumen of the catheter, with the proximal end of the implant at the strain relief portion of the catheter.The implant was stretched throughout the catheter, until the distal end of the coil was seen.The microcatheter does not have any indication of being smashed.The distal black pet covering the heater coil was removed.The heater coil looked to be intact, and the solder segments were normal.The attachment monofilament was dissected out of the pusher, and the tip of the monofilament was noted to be stretched.Based on the evaluation of the returned device, the reported complaint was confirmed, as the implant was returned detached from the pusher and stuck inside the microcatheter.The root cause for the implant becoming stuck could not be determined, as x-ray does not show any smashed segment damage on the catheter, or any clumping of the implant that created an oversized od.The root cause of the detachment could not be definitively determined; however, the implant most likely detached due to experiencing over specification of force.

• Brand Name: HYDROSOFT 3D ADVANCED
• Type of Device: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8584671
• MDR Text Key: 145270390
• Report Number: 2032493-2019-00119
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 00816777025487
• UDI-Public: (01)00816777025487(11)181112(17)231031(10)1811125W6
• Combination Product (y/n): N
• PMA/PMN Number: K161452
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 04/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Model Number: 7110-0310
• Device Lot Number: 1811125W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/29/2019
• Date Manufacturer Received: 04/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 50 YR