MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 5MMX20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035465200
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure, premature detachment of the coil was reported.The separation occurred at the detachment zone, when the coil was being retrieved out of the microcatheter to be re-sheathed into the introducer sheath.The coil was completely removed from the patient along with the microcatheter as a single unit.The procedure was completed successfully without any patient consequences due to the reported event.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the returned device revealed that the main coil was mechanically detached from the delivery wire and it was kinked.Additionally, the delivery wire and proximal contact were kinked likely due to the handling during use.The functional test could not be performed due to the condition of the returned device.Information available indicated that the resistance was encountered when the coil was advanced through the microcatheter and the coil was repositioned approximately eight times before removal.It is possible that the main coil was damaged and detached while being removed.Based on the information available and analysis, an assignable cause of operational context was assigned to this investigation.
Event or Problem Description
During the coil embolization procedure, premature detachment of the coil was reported.The separation occurred at the detachment zone, when the coil was being retrieved out of the microcatheter to be re-sheathed into the introducer sheath.The coil was completely removed from the patient along with the microcatheter as a single unit.The procedure was completed successfully without any patient consequences due to the reported event.

• Brand Name: TARGET 360 STANDARD 5MMX20CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 6323538
• Report Number: 3008881809-2017-00040
• Device Sequence Number: 10873440
• Product Code: HCG
• UDI-Device Identifier: 07613252239420
• UDI-Public: (01)07613252239420(17)190531(10)19034733
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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,Followup
• Report Date (Section B): 05/12/2017

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: 05/31/2019
• Device Catalogue Number: M0035465200
• Device Lot Number: 19034733
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/13/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/10/2017
• Supplement Report FDA Received Date: 05/12/2017
• 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: EXCELSIOR SL-10 (STRYKER)