MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 1CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035431510
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure the subject coil got detached on its own inside the catheter and had to be rescued out of the patient.There was a surgical delay of 5 minutes.The procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure the subject coil got detached on its own inside the catheter and had to be rescued out of the patient.There was a surgical delay of 5 minutes.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.D4 expiration date ¿ added.D4 gtin ¿ added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product meets specifications upon release.During the visual inspection, the subject coil was returned with the microcatheter.The coil delivery wire was noted to be kinked.The subject coil was seen to be detached and not returned.Functional inspection was not required.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 complaint was confirmed based on 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 subject coil detached inside the microcatheter and had to be retrieved from the patient.The device was confirmed to be in good condition prior to use and there is no indication of a use error.The patient¿s anatomy was not tortuous.The coil delivery wire was returned for analysis, and it was noted that the subject coil had separated due to a physical break at the detachment zone.An assignable cause of procedural factors will be assigned to the as reported and as analyzed code, ¿main coil prematurely detached/separated during use¿.The as analyzed code, ¿coil delivery wire kinked/bent¿ 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, and a probable cause of handling damage was assigned.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.

• Brand Name: TARGET HELICAL NANO 1.5MM X 1CM
• 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: 22891825
• Report Number: 3008881809-2025-00464
• Device Sequence Number: 15677617
• Product Code: HCG
• UDI-Device Identifier: 04546540698025
• UDI-Public: (01)04546540698025(17)290906(10)25151486
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2025

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: M0035431510
• Device Lot Number: 25151486
• 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: 09/24/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2024
• 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: PHENOM 17 DELIVERY CATHETER (UNKNOWN).
• Patient Sex: Unknown