MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2018
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 was advanced in the microcatheter, the coil got stuck and was detached prematurely.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.The subject device was returned protruding from a non-stryker microcatheter and the delivery wire or introducer sheath were not returned.Visual inspection of the device revealed that there was procedural fluid on the coil.The main coil was found to be stretched and prematurely detached (physical break at detachment zone).Functional testing could not be performed due to the damaged condition of the returned coil.The reported event of the coil premature detachment was able to be confirmed based on the information available and analysis of the device.The device was confirmed to be in good condition prior to use.Information available indicated that an incompatible microcatheter was used which can lead to buckling of the coil during advancement.As per the dfu "target detachable coils are compatible with stryker neurovascular 2-tip marker microcatheters (min.Internal diameter 0.41 mm [0.016 in], max.Internal diameter 0.48 mm [0.019 in])".Based on the information available, an assignable cause of use error was assigned to this event.
Event or Problem Description
It was reported that when the coil was advanced in the microcatheter, the coil got stuck and was detached prematurely.The coil was retrieved along with the microcatheter.There were no reported clinical consequences to the patient.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7558109
• Report Number: 3008881809-2018-00250
• Device Sequence Number: 13523927
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• 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): 07/30/2018

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: 10/31/2020
• Device Catalogue Number: M0035422040
• Device Lot Number: 20056498
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Initial Date Received by Manufacturer: 05/17/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 05/31/2018
• Supplement Report FDA Received Date: 07/30/2018
• 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 (ASAHI INTECC)