MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432060
Medical Device Problem Code	Migration or Expulsion of Device (1395)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during embolization procedure, a false detachment occurred and the coil came 2cm out of the vessel with the delivery wire.Some part of the coil was left hanging in the vessel.No additional procedure was performed.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.During visual inspection, the delivery wire was found kinked, and the main coil was partially detached mechanically from the delivery wire indicating that the detachment was not smooth confirming the reported complaint.Functional testing could not be performed due to the condition of the returned device.It is probable that the device was damage during the clinical procedure causing the as reported events.An assignable cause of procedural factors was assigned to the as analyzed and as reported issues 'main coil failed/unable to detach' and ' main coil protrusion ' as the issue is associated with a product that meets stryker design and manufacture specification and was used in according with the direction for use (dfu), but due to the procedural and/or anatomical factors during use, the device performance was limited.It is probable that the as analyzed defect ¿coil delivery wire was kinked/bent¿ was the result of handling of the device during the preparation of the device, or during clinical procedure; therefore, an assignable cause of handling damage was assigned as the issue was due to handling of the device or portion of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.Expiration date - added.Device evaluated by mfg - updated to yes.Manufacturing date - added.
Event or Problem Description
It was reported that during embolization procedure, a false detachment occurred and the coil came 2cm out of the vessel with the delivery wire.Some part of the coil was left hanging in the vessel.No additional procedure was performed.There were no clinical consequences reported due to this event.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7720256
• Report Number: 3008881809-2018-00321
• Device Sequence Number: 1107266
• Product Code: HCG
• UDI-Device Identifier: 04546540676016
• UDI-Public: 04546540676016
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2018

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: Health Professional
• Device Expiration Date: 02/16/2021
• Device Catalogue Number: M0035432060
• Device Lot Number: 20331635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2018
• Initial Date Received by Manufacturer: 06/28/2018
• Supplement Date Received by Manufacturer: 08/29/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1