MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035421520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The subject coil was returned for analysis and the device investigation revealed that the subject coil was broken/fractured during use.There was no clinical consequence to the patient due to this event.
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/microscopic inspection, the coil delivery wire was found to be kinked/bent.The main coil was found to be broken/fractured near the detachment zone.During functional testing, the reported coil in catheter friction could not be replicated during device analysis due to damage; however, the analysis results are consistent with the reported event.The reported main coil damage was confirmed.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 coil in catheter friction could not be replicated during device analysis due to damage; however, the analysis results are consistent with the reported event.The reported main coil damage was confirmed.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that while advancing the coil into the microcatheter, resistance was encountered, and the coil could not be advanced.The physician then withdrew the coil and found that it had been damaged.Additional information provided by the customer indicated that 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.The device was returned for analysis, and it was noted that the coil delivery wire was found to be kinked/bent, and the main coil was found to be broken/fractured near the detachment zone.The reported coil in catheter friction could not be replicated during device analysis due to damage; however, the analysis results are consistent with the reported event.The reported main coil damage was confirmed.An assignable cause of procedural factors will be assigned to the as reported coil in catheter friction and main coil damage as 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 procedural factors will be assigned to as analyzed main coil broken/fractured during use as 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 as analyzed coil delivery wire kinked/bent since this complaint appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 NANO 1.5MM X 2CM
• 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: 22146328
• Report Number: 3008881809-2025-00318
• Device Sequence Number: 20786523
• Product Code: HCG
• UDI-Device Identifier: 04546540697981
• UDI-Public: (01)04546540697981(17)290630(10)25016277
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K113412
• 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
• Report Date (Section B): 06/04/2025

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: M0035421520
• Device Lot Number: 25016277
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2024
• 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: SL-10 MICROCATHETER (STRYKER).
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Race: Asian