MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 6MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035476300
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection revealed the main coil was stretched and the suture was broken.The main coil was returned separated from the delivery wire and appeared to be have been mechanically detached.Although a functional testing could not be performed due to the condition of the returned device, the damage noted to the main coil would have caused friction in the catheter.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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the same microcatheter was used to complete the procedure.It is likely that the main coil broke due to manipulation against resistance.An assignable cause of procedural factors will be assigned to the reported event and to the analysed since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
Analysis of the returned device revealed that the subject device was broken during use.There were no clinical consequence to the patient reported as a result of this event.

• Brand Name: TARGET 360 SOFT 6MM X 30CM
• 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: 10451967
• Report Number: 3008881809-2020-00244
• Device Sequence Number: 14366531
• Product Code: HCG
• UDI-Device Identifier: 04546540676559
• UDI-Public: 04546540676559
• 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): 08/25/2020

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: 10/19/2022
• Device Model Number: M0035476300
• Device Catalogue Number: M0035476300
• Device Lot Number: 21870547
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 08/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR