MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182050
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/03/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable.
Event or Problem Description
It was reported that when the subject coil was retrieved because the subject coil size did not match aneurysm, it was stuck in the hub of the microcatheter and it was broken.Therefore, it was changed the new same one and the operation was continued.There were no clinical consequences to the patient due to this event.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.The subject device was not returned, therefore physical and functional tests could not be performed.However; the additional information states that intermittent flush was maintained during the procedure which is against the device direction for use (dfu) for this product.In the case of this complaint it is most likely that the main coil encountered difficulty and got stuck while getting retrieved to introducer sheath through hub of microcatheter due to intermittent flush maintained during the procedure.Therefore; an assignable cause of ¿user error¿ will be assigned to reported event, as the investigation confirmed that there was an act or omission of an act that resulted in a different medical device response than intended by the manufacturer and/or expected by the user.
Event or Problem Description
It was reported that when the subject coil was retrieved because the subject coil size did not match aneurysm, it was stuck in the hub of the microcatheter and it was broken.Therefore, it was changed the new same one and the operation was continued.There were no clinical consequences to the patient due to this event.

• Brand Name: TARGET XXL 360 20MM X 50CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8007178
• Report Number: 3008881809-2018-00466
• Device Sequence Number: 1386465
• Product Code: HCG
• UDI-Device Identifier: 07613327128345
• UDI-Public: 07613327128345
• 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): 11/16/2018

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: 03/18/2021
• Device Catalogue Number: M0036182050
• Device Lot Number: 20385715
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/03/2018
• Supplement Date Received by Manufacturer: 10/29/2018
• Initial Report FDA Received Date: 10/25/2018
• Supplement Report FDA Received Date: 11/16/2018
• 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 (LIGHT HOUSE /PIOLAX)
• Patient Age: 77 YR