MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 10MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Subject device is not available.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the coil through the microcatheter and the coil was prematurely detached.The coil was removed along with the microcatheter from the patient¿s anatomy.The procedure was completed using another device.There were no clinical consequences reported due to this event.
Additional Manufacturer Narrative
The electronic device history record (edhr) review confirms that the device met all material, assembly and performance specifications.The subject device was not returned for analysis; therefore, visual, dimensional and functional testing could not be performed.In case of this complaint, the additional information provided by the customer indicated that no anomalies noted to the device prior to use and the product was prepared as per direction for use (dfu).Also, continuous flush was maintained, and all movements were slow and smooth, in a one-to-one motion.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, an assignable cause of undeterminable was assigned to the as reported issue main coil prematurely detached/separated inside patient.Expiration date: added, manufacturing date: added.
Event or Problem Description
It was reported that during the procedure, resistance was encountered when advancing the coil through the microcatheter and the coil was prematurely detached.The coil was removed along with the microcatheter from the patient¿s anatomy.The procedure was completed using another device.There were no clinical consequences reported due to this event.

• Brand Name: TARGET XXL 360 10MM X 40CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8609724
• Report Number: 3008881809-2019-00127
• Device Sequence Number: 13998192
• Product Code: HCG
• UDI-Device Identifier: 07613327128406
• UDI-Public: 07613327128406
• Combination Product (Y/N): N
• PMA/510(K) Number: K161429
• 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): 06/25/2019

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: 12/02/2021
• Device Catalogue Number: M0036181040
• Device Lot Number: 21053001
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/25/2019
• Supplement Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/25/2019
• 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: HEADWAY 21 MICROCATHETER (MICROVENTION)