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

Model Number	7110-0310
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/07/2019
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8584671
• Report Number: 2032493-2019-00119
• Device Sequence Number: 13527095
• Product Code: HCG
• UDI-Device Identifier: 00816777025487
• UDI-Public: (01)00816777025487(11)181112(17)231031(10)1811125W6
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K161452
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Initial Date Received by Manufacturer: 04/07/2019
• Supplement Date Received by Manufacturer: 04/07/2019
• Initial Report FDA Received Date: 05/06/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 50 YR