MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 3 MM X 6 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035443060
Medical Device Problem Codes	Degraded (1153); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is not available.
Event or Problem Description
During the coil embolization procedure, it was reported when the physician pulled the microcatheter out, the detached coil (subject device) came together with the microcatheter.Even thought, it was confirmed under the fluoroscopy that the coil was successfully detached in the aneurysm and it looked like there was a little space between the coil and the microcatheter tip.So the detached coil was retrieved with the microcatheter.Upon review on the back table, it looked like the coil was somehow attached to the microcatheter.And stretch resistance material in the coil seems to be melted to the microcatheter tip.No clinical consequences reported to the patient.
Event or Problem Description
During the coil embolization procedure, it was reported when the physician pulled the microcatheter out, the detached coil (subject device) came together with the microcatheter.Even thought, it was confirmed under the fluoroscopy that the coil was successfully detached in the aneurysm and it looked like there was a little space between the coil and the microcatheter tip.So the detached coil was retrieved with the microcatheter.Upon review on the back table, it looked like the coil was somehow attached to the microcatheter.And stretch resistance material in the coil seems to be melted to the microcatheter tip.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The device history record (dhr) review confirmed that the device met all material, assembly and performance specifications.Analysis of the returned device found the main coil was kinked along its length and excessively stretched due to an excessive force being used during pushing/pulling activity against friction.No other additional anomalies were noted.The main coil was confirmed to be electrolytically detached at the junction.Functional testing could not be performed due to the condition of the returned device.In the case of this complaint, it was reported that the detached coil was pulled out from aneurysm together with the sl 10 microcatheter.In this case it is most probable that the coil did not exit the catheter completely before detachment and then it was pulled out of aneurysm with the catheter.The reported event was most likely due to some procedural/anatomical factors encountered during use which contributed to the event.Based on available information and investigation results, an assignable cause of operational problem due to component failure was assigned to this event.The issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the device direction for use (dfu) but due to procedural and/or anatomical factors during use, the device performance was limited.

• Brand Name: TARGET 360 NANO 3 MM X 6 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 7787243
• Report Number: 3008881809-2018-00350
• Device Sequence Number: 13498099
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• 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): 10/10/2018

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: 05/05/2021
• Device Catalogue Number: M0035443060
• Device Lot Number: 20516837
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/21/2018
• Initial Date Received by Manufacturer: 07/26/2018
• Supplement Date Received by Manufacturer: 09/19/2018
• Initial Report FDA Received Date: 08/15/2018
• Supplement Report FDA Received Date: 10/10/2018
• 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: SL-10 MICROCATHETER (STRYKER)