MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422540
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This is the 3rd of 4 reports.Subject device is not available.
Event or Problem Description
Patient successfully underwent coil embolization for an anterior communicating artery aneurysm with 4 coils (subject device) and a microcatheter.Next day magnetic resonance imaging (mri) showed an artifact.The ct image showed no sign.According to the physician, the artifact may be a marker for the product used.There were no clinical consequences to the patient.
Event or Problem Description
Patient successfully underwent coil embolization for an anterior communicating artery aneurysm with 4 coils (subject device) and a microcatheter.Next day magnetic resonance imaging (mri) showed an artifact.The ct image showed no sign.According to the physician, the artifact may be a marker for the product used.There were no clinical consequences to the patient.
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 as well as a functional evaluation could not be performed.Additional information provided by the customer indicated that there was no allegation against any of the devices used in the procedure.In addition, based on the review of mri (magnetic resonance imaging) provided by the customer, possibility of a metal artifact has been ruled out as ct (computed tomography) scan did not capture it.Other possibilities that it could be a micro hemorrhage, a tiny air bubble or a tiny foreign body emboli likely from the catheter coating.Therefore, the reported event was not confirmed as the ro (radiopaque) markers are made of metal.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 ULTRA 2.5MM 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: 8788857
• Report Number: 3008881809-2019-00203
• Device Sequence Number: 11429536
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: 04546540675866
• Combination Product (Y/N): N
• 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
• Report Date (Section B): 09/06/2019

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: 01/22/2022
• Device Catalogue Number: M0035422540
• Device Lot Number: 21162035
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/20/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 07/15/2019
• Supplement Report FDA Received Date: 09/06/2019
• 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: 1 EXCELSIOR SL-10 MICROCATHETER (STRYKER); 2 TARGET COILS (STRYKER); 1 EXCELSIOR SL-10 MICROCATHETER (STRYKER); 2 TARGET COILS (STRYKER)
• Patient Age: 76 YR