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

Model Number	100310HFRM-V
Medical Device Problem Codes	Stretched (1601); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Paresis (1998)
Date of Event	04/16/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A search for non-conformance 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 not returned to the manufacturer for evaluation; therefore, a product analysis could not be performed.The root cause is unknown.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 during an attempt to re-sheath the coil into the microcatheter, the coil stretched and detached at the detachment point.A solitaire stent was used to successfully retrieve the coil into a sofia catheter.The patient woke with hemiparesis; however, no bleeding or clot could be identified on ct scan.During follow-up the next morning on (b)(6) 2019, the patient was reported to have mostly recovered from the hemiparesis and is doing well.
Additional Manufacturer Narrative
Additional information: (concomitant medical products, device evaluated by mfr) the device was received for evaluation and analyzed.The pusher and implant were returned for analysis.The microcatheter, introducer, and dispenser hoop were not returned.Investigation into the returned unit found the proximal end of the implant to still be attached to the pusher.The marker band was still attached to the pusher and the implant was stretched distal to that location.The implant filar was broken at the stretched location.The implant was stretched through to the distal loops as noted by the customer.The pusher was found to be buckled at the heater coil location with evidence of twisting.Additional damage was found on the pusher in the form of bends and kinks.This damage is suspected to the result of handling prior to shipment back to microvention, but to be unrelated to the customer's experience.Based on the investigation findings and available information, the reported complaint is confirmed.A portion of the implant was found to be separated from the pusher.The bent damage to the pusher appeared to be related to shipping/handling rather than from the procedure.The root cause cannot be definitively identified, but the damage to the distal end of the pusher is historically related to excessive forces being placed on the pusher.It appears that it sustained compression and torsion forces.It is suspected that the implant was pinched and caught at the distal end of the microcatheter and pulled and manipulated upon retraction.

• Brand Name: HYDROSOFT 3D
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8616695
• Report Number: 2032493-2019-00145
• Device Sequence Number: 2180744
• Product Code: HCG
• UDI-Device Identifier: 00816777026590
• UDI-Public: (01)00816777026590(11)180515(17)230430(10)1805151W9
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K161367
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 04/30/2023
• Device Model Number: 100310HFRM-V
• Device Lot Number: 1805151W9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Initial Date Received by Manufacturer: 04/23/2019
• Supplement Date Received by Manufacturer: 04/23/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/20/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention