MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035423060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/09/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 main coil was returned protruding from the introducer sheath.The coil delivery wire was seen to be kinked/bent.The main coil was seen to be stretched.The main coil was seen to be tangled.The main coil suture was seen to be damaged.The main coil was seen to be broken/fractured.Functional inspection was not performed due to the subject device 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.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 subject coil could not be detached.Additional information provided by the customer indicated that there was no damage noted to the proximal section of the delivery wire prior to inserting into the power supply and proximal end of the delivery wire was wiped with alcohol.The rotating hemostatic valve (rhv) was sufficiently tightened prior to detachment and the power supply was maintained in a stable position.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.During visual inspection, the main coil was returned protruding from the introducer sheath.The coil delivery wire and main coil was seen to be kinked/bent.The main coil was also observed to be tangled and stretched.The functional analysis could not be performed since the main coil was returned broken from the delivery wire.Based on review of all available information, an assignable cause of procedural factors will be assigned to reported event ¿main coil failed/unable to detach¿ and analyzed events: ¿main coil stretched¿, ¿main coil suture damage¿, ¿main coil tangled¿, 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' since it is most likely that this damage occurred due to handling of delivery wire during the procedure.
Event or Problem Description
It was reported that during procedure the subject coil could not be detached.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.The subject device was returned for analysis and the device investigation revealed that the main coil was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 3MM 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: 21072720
• Report Number: 3008881809-2025-00009
• Device Sequence Number: 3417753
• Product Code: HCG
• UDI-Device Identifier: 04546540675880
• UDI-Public: (01)04546540675880(17)270609(10)24926470
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K120850
• 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): 01/03/2025

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: M0035423060
• Device Lot Number: 24926470
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/23/2024
• Initial Report FDA Received Date: 01/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/10/2024
• 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: INZONE POWER SUPPLY (STRYKER)
• Patient Age: 59 YR
• Patient Sex: Male