MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Analysis and the returned device revealed that the subject main coil and subject coil delivery wire were broken/fractured during use.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported 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 seen to be kinked/bent.The coil delivery wire was found to be broken/fractured near the detachment zone.The main coil was found to be stretched.The main coil suture was found to be damaged.The main coil was found to be only partially returned and found broken/fractured approximately 3 cm from the main junction.Functional inspection was unable to be performed.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; however, the analysis results are consistent with the reported event.The reported main coil stretched was confirmed during the analysis.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 resistance was encountered when the coil reached at the middle of the microcatheter, while the operator withdrew the coil, it was found to be stretched.Additional information provided by the customer indicated that the device was prepared 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 was noted to be kinked/bent and broken/fractured near the detachment zone.The main coil was found to be stretched, and the main coil suture was noticed to be damaged.The main coil was returned partially and was found broken/fractured approximately 3 cm from the main junction.An assignable cause of procedural factors will be assigned to as reported coil in catheter friction 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.Additional information provided by the customer indicated that the patient's anatomy was severely tortuous, so it's probable that the device got damaged due to procedural factors, hence an assignable cause of procedural factors will be assigned to the as analyzed main coil stretched, main coil suture damage, coil delivery wire broken/fractured during use and main coil broken/fractured 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 as analyzed coil delivery wire kinked/bent as this complaint appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET 360 ULTRA 2MM 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: 21566091
• Report Number: 3008881809-2025-00125
• Device Sequence Number: 4527988
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: (01)07613252239345(17)290622(10)25011954
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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
• Report Date (Section B): 03/10/2025

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: M0035422060
• Device Lot Number: 25011954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/17/2025
• Initial Report FDA Received Date: 03/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/24/2024
• 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: SL10 MICROCATHETER (STRYKER).
• Patient Age: 67 YR
• Patient Sex: Male
• Patient Race: Asian