MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that when the coil (subject device) was advanced in the microcatheter, the coil detached prematurely into the microcatheter.There were no reported clinical consequences to the patient.
Event or Problem Description
It was reported that when the coil (subject device) was advanced in the microcatheter, the coil detached prematurely into the microcatheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirms that the device met all material, assembly and performance specifications.The subject device was returned within the dispenser hoop.Visual & microscope inspection revealed that the, the coil delivery wire was kinked likely due to handling.The main coil was observed to be broken near the coil junction.The main coil was not returned for analysis.Functional testing could not be performed due to the damaged condition of the returned device.Information available indicated that resistance was observed during insertion of the coil in the microcatheter.Based on the information currently available, it is probable that some procedural factors encountered during the procedure limited the performance of the coil contributing to the reported and observed damages.Therefore, an assignable cause of component failure has been assigned to this investigation.

• Brand Name: TARGET 360 SOFT 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8341555
• Report Number: 3008881809-2019-00045
• Device Sequence Number: 16194719
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K153658
• 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): 04/01/2019

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: 07/15/2021
• Device Catalogue Number: M0035475150
• Device Lot Number: 20729363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 01/29/2019
• Supplement Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 04/01/2019
• 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: ECHELON MICROCATHETER (MEDTRONIC)