MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035477200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a middle cerebral artery (mca) bifurcation aneurysm case, operator tried to adjust the position of the subject coil within the aneurysm the subject coil was not able to be retracted, nor it was moving.When the subject coil was slowly retrieved it was found to be stretched.The procedure was completed successfully with another device without any clinical consequences to the patient.The subject coil was returned for analysis and the device investigation revealed that the subject main coil was prematurely detached /separated during use.
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, it was observed that the subject coil delivery wire was seen to be kinked bent in multiple areas and the main coil was seen to be detached /separated from the delivery wire.Functional inspection for reported main coil stretch could not be confirmed as the main coil wasn¿t returned.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 not confirmed based on analysis of the returned device.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated that the device was prepared for use as per the directions for use.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.The continuous flush was set up and maintained throughout the clinical procedure.The device was returned for analysis, and it was noted that the delivery wire was seen to be kinked/bent in multiple areas.The main coil was seen to be detached/separated from the delivery wire.On functional inspection, the reported main coil stretched and the device difficulty engaging target vessel could not be confirmed as the main coil was not returned.The reported as reported codes device difficulty engaging target vessel and main coil stretched were not confirmed and will be assigned a probable cause of not confirmed.The as analyzed codes coil delivery wire kinked/bent, and main coil prematurely detached /separated during use will be assigned a probable cause of procedural factors 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.

• Brand Name: TARGET 360 SOFT 7MM X 20CM
• 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: 21208607
• Report Number: 3008881809-2025-00052
• Device Sequence Number: 17129538
• Product Code: HCG
• UDI-Device Identifier: 04546540676573
• UDI-Public: (01)04546540676573(17)270324(10)24866539
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/22/2025

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: M0035477200
• Device Lot Number: 24866539
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/30/2024
• Initial Report FDA Received Date: 01/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER); XINWEI MIDDLE CATHETER (UNKNOWN)
• Patient Sex: Unknown
• Patient Race: Asian