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

Model Number	100308HFRM-V
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Environmental Compatibility Problem (2929)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/30/2019
Type of Reportable Event	Malfunction
Additional 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 not returned for analysis.The root cause is unknown.The instructions for use (ifu) identifies premature coil detachment as a potential complication associated with use of the device.
Event or Problem Description
It was reported that during an embolization of an ica supraclinoid ruptured aneurysm, resistance was encountered when advancing an embolization coil in the microcatheter.The coil was unable to advance, and it was removed from the patient.During inspection of the device, it was observed that the implant coil had detached inside of the microcatheter.There was no reported intervention or patient injury.
Additional Manufacturer Narrative
Corrected data: (h3)(d10) the pusher, introducer, and dispenser hoop were returned for analysis.The implant was found in the microcatheter.The implant was stretched and separated from the pusher.The implant separated due to retraction forces that exceeded the strength of the monofilament.The microcatheter contained multiple kinks.Investigation found the introducer to be in good condition and without damage.The pusher was found to have minor offsetting on the body coil approx.10" from the heater coil.The heater coil was found to burned, indicating attempted detachment.Contamination was additionally noted on the gold connector, creating intermittent contact with the v-grip.The reported complaint is confirmed.The physical evaluation of the returned coil system found the implant to be stretched, separated from the pusher, and returned stuck in the microcatheter.Based on the condition of the implant, the investigation determined that it had stretched and separated from the pusher due to it becoming stuck in a damaged microcatheter and then experiencing retraction forces that exceeded the strength of the coil winding and monofilament.

• Brand Name: HYDROSOFT 3D
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 8871926
• Report Number: 2032493-2019-00182
• Device Sequence Number: 10941005
• Product Code: HCG
• UDI-Device Identifier: 00816777026583
• UDI-Public: (01)00816777026583(11)181219(17)231130(10)1812191W6
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 07/08/2019

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: 11/30/2023
• Device Model Number: 100308HFRM-V
• Device Catalogue Number: 100308HFRM-V
• Device Lot Number: 1812191W6
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/20/2019
• Initial Date Received by Manufacturer: 07/08/2019
• Supplement Date Received by Manufacturer: 07/08/2019
• Initial Report FDA Received Date: 08/07/2019
• Supplement Report FDA Received Date: 09/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 54