MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the coil delivery wire was seen to be kinked.The main coil was seen to be detached/separated and not returned.The coil introducer sheath was intact.Functional inspection was unable to perform due to damage.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 physician encountered resistance while advancing the subject coil through the microcatheter.The procedure was successfully completed by replacing the coil with a new one using the same microcatheter.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.An assignable cause of procedural factors will be assigned to the reported even of coil in catheter friction as it could not be replicated during analysis however, the analysis results are consistent with the reported event.It is probable that the subject coil was advanced or retracted against resistance, which may have caused premature detachment from the delivery wire, resulting in the observed defects in the device.An assignable cause of procedural factors will be assigned to analyzed damage of the main coil prematurely detached/separated during use 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 analyzed damage of the coil delivery wire kinked/bent since this issue is most likely 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
The device was returned for analysis and the investigation of the device revealed that the coil (subject device) prematurely detached/separated during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL ULTRA 2MM X 8CM
• 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: 23618107
• Report Number: 3008881809-2025-00660
• Device Sequence Number: 13261295
• Product Code: HCG
• UDI-Device Identifier: 04546540676023
• UDI-Public: (01)04546540676023(17)300214(10)25475506
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• PMA/510(K) Number: K242243
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/21/2025

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: M0035432080
• Device Lot Number: 25475506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/28/2025
• Initial Report FDA Received Date: 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2025
• 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
• Patient Sex: Male