MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475200
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device is not available to manufacturer.
Event or Problem Description
It was reported that a coil (subject device) failed to detach when an attempt was made to detach it with a detachment system.The tail of the delivery wire was found fractured when the subject coil was removed during the procedure.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date added.H3 device evaluated by mfg updated.H3 summary attached updated.D4 expiration date added.D9 product available to stryker updated.D9 returned to manufacturer on 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 proximal contact was seen to be detached from the pusher wire and due to this, the coil would not detach successfully.During functional inspection, the coil did not detach successfully.The reported coil delivery wire broken/fractured during use was not confirmed during the investigation.It is probable that the detached proximal contact found during analysis was interpreted as the coil delivery wire in the reported event.The reported main coil failed/unable to detach was able to be confirmed based on the damage noted to the proximal contact.The device failed to meet specifications when received for complaint investigation.Additional information was provided by the customer stated the device was confirmed to be in good condition during preparation/prior to use on the patient and the device prepared for use as per the directions for use.It is probable that the proximal contact detached/separated in the attempt to insert the the proximal end of the delivery wire into the inzone to complete the coil detachment, resulting in the failure to detach the main coil.An assignable cause of procedural factors will be assigned to the reported and as analyzed main coil failed/unable to detach, as the issue is associated with a product that meets design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.It is probable that the proximal contact detached as a result of handling of the device during preparation of the device or during advancement of the device.An assignable cause of handling damage will be assigned to the analyzed defect coil proximal contact detached/separated.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that a coil (subject device) failed to detach when an attempt was made to detach it with a detachment system.The tail of the delivery wire was was found fractured when the subject coil was removed during the procedure.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 5MM X 20CM
• 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: 10974155
• Report Number: 3008881809-2020-00383
• Device Sequence Number: 3241256
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: 04546540676511
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/11/2021

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: 11/27/2022
• Device Model Number: M0035475200
• Device Catalogue Number: M0035475200
• Device Lot Number: 21959952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 02/16/2021
• Initial Report FDA Received Date: 12/09/2020
• Supplement Report FDA Received Date: 03/11/2021
• 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).; INZONE DETACHMENT SYSTEM (STRYKER).; EXCELSIOR SL-10 MICROCATHETER (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Age: 61 YR