MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424060
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during the procedure the subject coil had to be repositioned for placement.When the coil was retrieved back into the catheter, it detached and was fractured into two parts.One fragment was removed from the catheter and one fragment remained in the catheter.The device was replaced, and the procedure was completed successfully.
Additional Manufacturer Narrative
Section b1 product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.Section d4 expiration date, gtin- updated.Section d9- product available to stryker, returned to manufacturer on: updated.Section h4- mfg.Date- updated.B5 - executive summary - updated.Due to the automated manufacturing execution system (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 noted to be kinked in two locations.The main coil was stretched and the suture damaged.For the functional test, the friction functional test could not be carried out due to damage.The reported event is covered in the device direction 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 coil in catheter friction could not be replicated; however, the analysis results are consistent with the reported event.The reported main coil broken/fractured during use and main coil prematurely detached/separated during use was not confirmed during analysis.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 detached and got stuck at the distal tip of the microcatheter.The coil was also observed to have broken into two parts.Additional information provided by the customer indicated that 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 was adequately tightened while the introducer sheath was in the hub (not over/under-tightened).During analysis, the coil delivery wire was noted to be kinked.The main coil was stretched and had damaged sutures.The reported main coil broken/fractured during use and main coil prematurely detached/separated during use was not confirmed during analysis, hence an assignable cause of not confirmed will be assigned.An assignable cause of procedural factors will be assigned to reported coil in catheter friction as well as, as analyzed main coil stretched and main coil suture damage since the complaint appears to be associated with a product that met company¿s 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 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 the 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 during the procedure the subject coil had to be repositioned for placement.When the coil was retrieved back into the catheter, it detached and was fractured into two parts.One fragment was removed from the catheter and one fragment remained in the catheter.The device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject coil was returned for analysis and was examined, and it was discovered that the reported event of the subject main coil was detached at the distal end of microcatheter shaft and was broken into two parts during use was not confirmed.The subject coil delivery wire was found to be kinked, the main coil was found to be stretched, and the suture of subject main coil was found to be damaged.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 4MM X 6CM
• 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: 22586491
• Report Number: 3008881809-2025-00403
• Device Sequence Number: 11903430
• Product Code: HCG
• UDI-Device Identifier: 04546540675910
• UDI-Public: (01)04546540675910(17)300415(10)25556594
• Combination Product (Y/N): N
• Initial Reporter Country: ID
• 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): 08/13/2025

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: M0035424060
• Device Lot Number: 25556594
• 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: 07/03/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/17/2025
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 27 YR
• Patient Sex: Female