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

Model Number	M0035443060
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject coil delivery wire would not advance or pull back through the microcatheter and partially deployed once placed inside the aneurysm.The subject coil and microcatheter were successfully removed from the aneurysm.The previous coil that was already in the aneurysm was not displaced by the removal of the subject coil.There were no clinical consequences to the patient reported due to this event.
Additional Manufacturer Narrative
H3 device evaluated by mfg ¿updated.H3 summary attached - updated.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 coil delivery wire was severely kinked/bent and the main coil was returned protruding from the catheter tip.The coil was found jammed and could not be advance; therefore, the catheter was cut to remove the coil.Functional testing was unable to carry out due to the condition of the returned device.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.The damage noted to the device would be indicative of the as reported defect.It was seen that the main coil was jammed in the catheter shaft.The delivery wire was also seen to be kinked/bent.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, preparation/set-up was performed as per the dfu and continuous flush was maintained for the duration of the procedure.During analysis it could not be said for definite whether the coil was detached or not in the catheter shaft as it was jammed.Therefore, the as reported defect coil jammed can be confirmed.The as reported/analyzed defect coil jammed as well as the analyzed defect coil in catheter friction was assigned procedural factors as these defects 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 or anatomical factors during use.The as reported defect main coil prematurely detached during use could not be determined as review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.The as analyzed defect coil delivery wire kinked bent was assigned handling damage as the issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.
Event or Problem Description
It was reported that during the procedure, the subject coil delivery wire would not advance or pull back through the microcatheter and partially deployed once placed inside the aneurysm.The subject coil and microcatheter were successfully removed from the aneurysm.The previous coil that was already in the aneurysm was not displaced by the removal of the subject coil.There were no clinical consequences to the patient reported due to this event.

• Brand Name: TARGET 360 NANO 3MM X 6CM
• 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: 11654396
• Report Number: 3008881809-2021-00160
• Device Sequence Number: 19889968
• Product Code: HCG
• UDI-Device Identifier: 07613252600329
• UDI-Public: 07613252600329
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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): 08/03/2021

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: 11/30/2023
• Device Model Number: M0035443060
• Device Catalogue Number: M0035443060
• Device Lot Number: 22617316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/06/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 07/07/2021
• Initial Report FDA Received Date: 04/13/2021
• Supplement Report FDA Received Date: 08/03/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)