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

Model Number	M0035475150
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during coil embolization procedure, the coil prematurely detached within the microcatheter.The neuroradiologist was able to place the coil in the aneurysm without any patient clinical consequences.
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, physical as well as a functional testing could not be performed.The reported issue is covered in the device directions for use.The risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.
Event or Problem Description
It was reported that during coil embolization procedure, the coil prematurely detached within the microcatheter.The neuroradiologist was able to place the coil in the aneurysm without any patient clinical consequences.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection revealed that the coil delivery wire and the main coil were kinked/bent and the main coil was found to be stretched.During functional testing, friction was noted in the introducer sheath.However, the reported premature detachment could not be confirmed.Therefore, an assignable cause of "not confirmed" has been assigned to the reported event.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during coil embolization procedure, the coil prematurely detached within the microcatheter.The neuroradiologist was able to place the coil in the aneurysm without any patient clinical consequences.

• 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 ; IE NA
• MDR Report Key: 8894346
• Report Number: 3008881809-2019-00242
• Device Sequence Number: 10814345
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/06/2020

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: 06/02/2022
• Device Model Number: M0035475150
• Device Catalogue Number: M0035475150
• Device Lot Number: 21478256
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: 08/05/2019
• Supplement Date Received by Manufacturer: 10/11/2019; 07/17/2020
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 10/21/2019; 08/06/2020
• 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: MICROCATHETER UNKNOWN MANUFACTURER)