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

Catalog Number	M0035475200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, after about three loops were coiled in the aneurysm, when the subject coil delivery wire was pulled back for engaging with the vessel, the coil did not come along.When the subject coil was removed with the entire microcatheter from the body, the coil was found to be prematurely detached.The first six loops were in the aneurysm, and the rest of subject coil and the delivery wire were removed from the microcatheter shaft after they were removed along with the microcatheter from the body.The coil was replaced and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.H3 device evaluated by mfg ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the coil delivery wire was seen to be kinked.The subject coil was detached.The subject coil was seen to have stretched near the detachment zone.Functional inspection was not required.The reported complaint was confirmed based on visual inspection.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the 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.It was reported that the subject coil detached during repositioning.The detached subject coil was removed together with the microcatheter.The procedure was completed successfully using another coil with the same microcatheter.The device was returned and it was confirmed that the subject coil had detached due to a physical break at the detachment zone.An assignable cause of procedural factors will be assigned to the as reported/ as analyzed, 'main coil prematurely detached/separated during use' and to the as analyzed, 'main coil stretched' as the issue is associated with a product that meets stryker 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.An assignable cause of handling damage will be assigned to the as analyzed, 'coil delivery wire kinked/bent' as the issue appears to be associated with handling of the product or portion of the product during the procedure /upon removal of the product from the packaging / preparation of the product prior to use.
Event or Problem Description
It was reported that during the procedure, after about three loops were coiled in the aneurysm, when the subject coil delivery wire was pulled back for engaging with the vessel, the coil did not come along.When the subject coil was removed with the entire microcatheter from the body, the coil was found to be prematurely detached.The first six loops were in the aneurysm, and the rest of subject coil and the delivery wire were removed from the microcatheter shaft after they were removed along with the microcatheter from the body.The coil was replaced and the procedure was completed successfully with no 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
• Manufacturer (Section G): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• Manufacturer Contact: tara lopez ; 47900 bayside parkway; fremont, CA 94538 ; 5104132500
• MDR Report Key: 22895984
• Report Number: 3008881809-2025-00465
• Device Sequence Number: 5802680
• Product Code: HCG
• UDI-Device Identifier: 04546540676511
• UDI-Public: (01)04546540676511(17)271118(10)25293559
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K242243
• 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): 10/16/2025

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 Catalogue Number: M0035475200
• Device Lot Number: 25293559
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/08/2025
• Supplement Date Received by Manufacturer: 09/25/2025
• Initial Report FDA Received Date: 08/26/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown