MAUDE Adverse Event Report: MICROVENTION, INC. MICROPLEX HELICAL SR SFT 10VTA; EMBOLIZATION COIL

Model Number	100208HCSR-S-V
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2018
Type of Reportable Event	Malfunction
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 was not returned to the user facility; therefore, a product evaluation could not be performed.The root cause is unknown.
Event or Problem Description
It was reported that during an embolization procedure, the coil detached in the microcatheter.Both segments of the coil were removed in their entirety from the patient.There was no reported intervention or patient injury.The patient was reported to be doing good.
Additional Manufacturer Narrative
The device was returned with introducer, pusher, and the implant coil; which was returned detached from the pusher.The pusher was noted to be sheathed withinthe introducer.The introducer tip was noted to be damaged.When removing the pusher from the introducer, friction was encountered, which was partially due to the damage on the introducer tip, as well as an over specification of the outer diameter at the attachment bond area of the pusher.The hypotube of the pusher contained minor bends just proximal and middle of the hypotube and body coil weld.The heater coil strain relief did not contain any burn marks.The connectivity of the pusher was investigated; testing revealed that it failed resistance and the 4-way v-grip test.The strain relief was removed from the distal of the pusher; the heater coil was noted to be broken off the pusher body coil, and both lead wires were no longer connected to the heater coil.The attachment monofilament was retrieved from the pusher, where the breakage tip was examined.The monofilament tip was noted to be stretched.The implant coil was misshapen, but did not contain any damage to the coils.The tie knot area was also noted to be intact.There were no other notable observations.Based upon the investigation findings and available information, the reported complaint can be confirmed.The coil was detached from the pusher.The root cause cannot be determined; however, the device exhibits evidence that it 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: MICROPLEX HELICAL SR SFT 10VTA
• Common Device Name: EMBOLIZATION COIL
• Manufacturer (Section D): MICROVENTION, INC.; 35 enterprise drive; aliso viejo CA 92656
• MDR Report Key: 7625459
• Report Number: 2032493-2018-00118
• Device Sequence Number: 11082117
• Product Code: HCG
• UDI-Device Identifier: 00816777020369
• UDI-Public: (01)00816777020369(11)180125(17)221231(10)1801251WB
• Combination Product (Y/N): N
• Initial Reporter Country: UP
• PMA/510(K) Number: K050954
• 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): 05/23/2018

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: Physician
• Device Expiration Date: 12/31/2022
• Device Model Number: 100208HCSR-S-V
• Device Lot Number: 1801251WB
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 05/23/2018
• Initial Report FDA Received Date: 06/21/2018
• Supplement Report FDA Received Date: 08/06/2018
• 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