MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036181450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2024
Type of Reportable Event	Malfunction
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 and microscopic inspection, it was observed that the subject device was returned without the transport hoop.The coil delivery wire was seen to be kinked/bent.The main coil was found to be detached/separated from the delivery wire.The main coil was not returned.Functional inspection couldn't be performed due to the condition of the returned device.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.During analysis, the coil delivery wire was noted to be kinked, and the main coil was found to be detached/separated from the delivery wire.An assignable cause of procedural factors will be assigned to the as reported codes main coil stretched and coil in catheter friction and also analyzed code main coil prematurely detached separated 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 clinical procedure.
Event or Problem Description
It was reported that distal end of the subject coil got stretched and resistance was encountered advancing the subject coil in the microcatheter.The subject coil was returned for analysis and the device investigation revealed that the subject main coil was found to be detached/separated from the delivery wire during use.

• Brand Name: TARGET XXL 360 14MM X 50CM
• 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: 21169436
• Report Number: 3008881809-2025-00041
• Device Sequence Number: 4336448
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: (01)07613327128383(17)260729(10)24446513
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 01/16/2025

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 Expiration Date: 07/29/2026
• Device Catalogue Number: M0036181450
• Device Lot Number: 24446513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2024
• 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: 01/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/31/2023
• 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: CARRY LEON MICROCATHETER (T&M).
• Patient Sex: Prefer Not To Disclose