MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the embolism procedure, the subject coil could not detach at the aneurysm when the physician attempted to deploy it.However, the subject coil prematurely detached inside the microcatheter when it was being removed from the patient¿s anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was received.The reported lot number was confirmed from the packaging label.During the visual inspection, the coil delivery wire was noted to be kinked/bent.The main coil was noted to be detached from the coil delivery wire.There was evidence of thrombus & procedural fluids to the distal end of the delivery wire and detachment zone.Functional inspection could not be performed as the main coil was not recovered.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.As per the additional information, the device was confirmed to be in good condition during preparation/prior to use on the patient and continuous flush set up and maintained throughout the clinical procedure.The device was returned and it was confirmed that the main coil had been detached from the delivery wire, there was evidence of thrombus/procedural fluids to the distal end of the delivery wire/ detachment zone, which may have cause or contributed to the reported failure to detach.It is probable that the target coil failed to detach or was partially detached and was subsequently prematurely detached within the microcatheter during the attempt to remove the coil.An assignable cause of procedural factors will be assigned to the reported main coil failed/unable to detach and main coil prematurely separated/detached during use and to the analyzed coil delivery wire kinked/bent and main coil prematurely detached/separated during use, as this complaint 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 embolism procedure, the subject coil could not detach at the aneurysm when the physician attempted to deploy it.However, the subject coil prematurely detached inside the microcatheter when it was being removed from the patient¿s anatomy.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 2MM X 3CM
• 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: 12147641
• Report Number: 3008881809-2021-00296
• Device Sequence Number: 14597554
• Product Code: HCG
• UDI-Device Identifier: 07613252600312
• UDI-Public: 07613252600312
• 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): 10/27/2021

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: 11/10/2022
• Device Model Number: M0035442030
• Device Catalogue Number: M0035442030
• Device Lot Number: 21928948
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2021
• Initial Date Received by Manufacturer: 06/18/2021
• Supplement Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 10/27/2021
• 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: INZONE POWER SUPPLY (STRYKER).; SL-10 MICROCATHETER (STRYKER).; UNKNOWN MICROCATHETER.