MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the device revealed that the main coil was detached from the delivery wire due to a physical break at the detachment zone.The main coil was also found to be stretched and the suture damaged.The delivery wire and proximal contact were kinked likely due to handling.Functional testing could not be performed due to the condition of the device.Information available indicated that the microcatheter used in the procedure had an internal diameter of 0.021in which is not compatible with this target coil (too large).In the case of this complaint the coil had too much space inside the microcatheter.As per the dfu for this product the largest compatible microcatheter that can be used with this target coil is an excelsior 1018, 2-tip marker (internal diameter 0.48 mm [0.019 in]) microcatheter.Information available indicated that the target coil was confirmed to be in good condition prior to use, resistance was experienced during advancement and that it became jammed inside the microcatheter.It is probable that the coil began taking shape when used with the 0.021 id microcatheter.The main coil likely stretched while it was being removed from the microcatheter and force used during removal contributed to the main coil suture brake and detachment from the delivery wire.Based on analysis of the device and information available an assignable cause of use error was assigned to this investigation.
Event or Problem Description
Analysis of the device revealed that the main coil detached from the delivery due to a physical break at the detachment zone.There were no reported clinical consequences to the patient.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6112614
• Report Number: 3008881809-2016-00264
• Device Sequence Number: 16424955
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: (01)04546540676023(17)181130(10)18683924
• Combination Product (Y/N): N
• PMA/510(K) Number: K112385
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2016

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: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: M0035432080
• Device Lot Number: 18683924
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2016
• Initial Report FDA Received Date: 11/18/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TERUMO MICROCATHETER (UNKNOWN)