MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422540
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/27/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an acute coiling procedure, an attempt was made to deliver the subject coil through the microcatheter, but it would not advance.When retrieval was attempted, the coil remained stuck and eventually snapped within the microcatheter.The procedure was delayed by 15 minutes, with no adverse impact on the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.H3 device evaluated by mfg ¿updated.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated mes (manufacturing execution system) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the device was returned with the microcatheter.The coil delivery wire was found to be kinked/bent in multiple areas.The main coil was found to be stretched.The main coil was found to be kinked/bent.The main coil suture was found to be damaged.During a functional inspection, the reported main coil prematurely detached /separated during use was not confirmed during the analysis.The reported coil in catheter friction and main coil friction could not be replicated during device analysis; however, the analysis results are consistent with the reported event.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 reported 'main coil prematurely detached /separated during use' was not confirmed during the analysis.The reported 'coil in catheter friction' and 'main coil friction' could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that the coil and the microcatheter were stuck inside.When the operator attempted to retrieve them, they wouldn¿t come out and eventually snapped off inside the microcatheter.Additional information provided by the customer indicated that resistance was noted while the coil was advancing the microcatheter.The tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter (with a slight buckling or reactive force indicating proper positioning).The rhv (rotating hemostasis valve) was adequately tightened while the introducer sheath was in the hub.While the introducer sheath was seated at the hub, the rhv was opened enough to allow passage of the device through without damage.When advancing the coil within the microcatheter, the rhv was opened enough to allow passage of the device through without damage.Excessive force was not applied at any point while advancing the coil within the microcatheter.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.The device was confirmed to be in good condition during preparation/ prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.During analysis, the coil delivery wire and main coil was found to be kinked.The main coil was found to be kinked, and the main coil suture was found to be damaged.The device was returned with the microcatheter.The reported main coil prematurely detached /separated during use was not confirmed during the analysis hence an assignable cause of not confirmed will be assigned.An assignable cause of procedural factors will be assigned to as reported 'coil in catheter friction' and 'main coil friction' as well as analyzed 'main coil kinked/bent', 'main coil suture damage' and 'main coil stretched' 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 factors during use.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since it is most likely that this damage occurred due to handling of delivery wire during the clinical procedure.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 during an acute coiling procedure, an attempt was made to deliver the subject coil through the microcatheter, but it would not advance.When retrieval was attempted, the coil remained stuck and eventually snapped within the microcatheter.The procedure was delayed by 15 minutes, with no adverse impact on the patient.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 2.5MM X 4CM
• 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: 21762348
• Report Number: 3008881809-2025-00186
• Device Sequence Number: 8582656
• Product Code: HCG
• UDI-Device Identifier: 04546540675866
• UDI-Public: (01)04546540675866(17)291104(10)25257981
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 05/30/2025

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: M0035422540
• Device Lot Number: 25257981
• 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: 03/27/2025
• Supplement Date Received by Manufacturer: 05/12/2025
• Initial Report FDA Received Date: 04/03/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2024
• 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 (NON-STRYKER).
• Patient Age: 54 YR
• Patient Sex: Female