MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that during the procedure, when the subject coil was advancing within the microcatheter, resistance was encountered.When the subject coil was removed it was found to have broken in the middle section.The physician took the micro catheter outside the body and flushed it to completely remove the subject coil fragments.The procedure was completed without clinical consequences to the patient.
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.The reported complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.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 tortuosity of the patient's anatomy was average, the rotating hemostatic valve (rhv) was opened enough to allow passage of the device through without damage, no excessive force was applied while advancing the coil, no torque was given where advancing the delivery wire, and the coil broke while advancing the coil within the microcatheter.The broken coil was removed by taking the microcatheter outside the body and flushing.In the case of this complaint, it is probable that resistance encountered in the microcatheter during the procedure contributed to the coil breaking during advancement.An assignable cause of procedural factors will be assigned to this complaint as this issue appears 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
It was reported that during the procedure, when the subject coil was advancing within the microcatheter, resistance was encountered.When the subject coil was removed it was found to have broken in the middle section.The physician took the micro catheter outside the body and flushed it to completely remove the subject coil fragments.The procedure was completed without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 11587212
• Report Number: 3008881809-2021-00147
• Device Sequence Number: 11602099
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: 04546540697981
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 07/08/2021

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: 02/24/2023
• Device Model Number: M0035421520
• Device Catalogue Number: M0035421520
• Device Lot Number: 22163142
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/02/2021
• Supplement Date Received by Manufacturer: 07/01/2021
• Initial Report FDA Received Date: 03/30/2021
• Supplement Report FDA Received Date: 07/08/2021
• 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: MICRO CATHETER (UNKNOWN)