MAUDE Adverse Event Report: MICROVENTION, INC. HYDROFILL HELICAL; EMBOLIZATION COIL

Model Number	100720HFIL-V
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The lot number was provided.A review of the approved device history record indicated the lot met all release criteria.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 for analysis.The investigation is currently underway.
Event or Problem Description
It was reported that the coil detached in the microcatheter.A snare device was used to successfully retrieve the coil from the carotid artery.There was no reported patient injury.
Additional Manufacturer Narrative
The device was returned with the introducer and pusher for analysis.The pusher was sheathed within the introducer and the dispenser hoop.The introducer with the pusher had to be removed through the gap in the dispenser hoop tubing for analysis.The body coil distal of the attachment bond area of the pusher was noted to be damaged and stretched.The distal portion was tangled, which caused the pusher to be stuck in the dispenser hoop.The distal tip of the pusher was analyzed.The heater coil was noted to be compressed.The strain relief did not have evidence of burn marks, and the lead wires were not attached.The strain relief was removed from the heater coil section, which confirmed compression damage.The lead wires were noted to be absent.The attachment bond area of the pusher was still intact.The length of the remaining attachment monofilament was within specifications, and the tip was noted to be stretched.The tip of the lead wire was stretched.The remaining attachment monofilament and lead wires length found between attachment bond to heater coil were within specification.There were no other notable observations were found on remainder of the pusher or introducer.Based upon the investigation findings and available information, the reported complaint can be confirmed.There was no evidence of burn marks at the strain relief, which indicates the heater coil was not activated for a coil detachment.The root cause cannot be determined; however, the device exhibits evidence that the monofilament was subjected to tensile forces that exceeded its strength specifications.The instructions for use (ifu) identifies premature or difficult coil detachment as potential complications associated with use of the device.

• Brand Name: HYDROFILL HELICAL
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7871430
• Report Number: 2032493-2018-00183
• Device Sequence Number: 2012784
• Product Code: HCG
• UDI-Device Identifier: 00810170017254
• UDI-Public: (01)00810170017254(11)180215(17)230131(10)1802151RE
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K113457
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2018

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: 01/31/2023
• Device Model Number: 100720HFIL-V
• Device Lot Number: 1802151RE
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2018
• Supplement Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/12/2018
• Supplement Report FDA Received Date: 10/05/2018
• 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