MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421020
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was noted to be stretched and the suture was damaged.The main coil was also noted to be broken/fractured.Functional testing was not performed due to the damages noted to the returned coil.The reported event is covered in the device directions for use (dfu).As well, the risk of the reported event is documented in the risk documentation and there are current controls to mitigate the risk of the as reported event.In case of this complaint, the main coil was found to be broken and stretched.In case of this complaint, it is most likely that the main coil was stretched and broken when advancing/retracting when trying to position the device.This complaint appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors; therefore, an assignable cause of procedural factors will be assigned to the as reported and as analyzed issues.This is 2nd of 2 reports.
Event or Problem Description
Analysis of the returned device found that the subject main coil was broken/fractured.There were no clinical consequence to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; IE NA
• MDR Report Key: 10353849
• Report Number: 3008881809-2020-00223
• Device Sequence Number: 3463833
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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
• Report Date (Section B): 07/31/2020

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: 05/01/2021
• Device Model Number: M0035421020
• Device Catalogue Number: M0035421020
• Device Lot Number: 20510936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/12/2020
• Initial Report FDA Received Date: 07/31/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 80