MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 20MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036182050
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure there was resistance when the subject coil was advanced through the introducer sheath and shaft of microcatheter and the subject coil got prematurely detached within the microcatheter during advancement.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
H3 device evaluated by mfg ¿updated.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 main coil was returned inside the microcatheter.The main coil was found to be stretched.The main coil was found to be kinked/bent.The main coil suture was found to be damaged.The coil delivery wire was found to be broken/fractured close to the detachment zone.During functional test, the microcatheter was flushed and 0,0158¿ patency mandrel was advanced through, the mandrel got stuck approximately 97cm from the hub.The shaft was then cut, and the main coil was removed with difficulty.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 codes coil introducer sheath friction and coil in catheter friction could not be replicated; however, the analysis results are consistent with the reported event.The reported main coil prematurely detached separate was not confirmed during the 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 the coil got prematurely detached within the microcatheter during advancement.Additional information provided by the customer indicated that there was friction while the coil was advancing the introducer sheath.The physician encountered friction at the shaft of the microcatheter.The tapered distal end of the introducer sheath was firmly seated in the hub of microcatheter.The device was prepared for use as per the dfu.There was no damage noted to the packaging/device prior to use on the patient.The device had no defect at the time of preparation.Continuous flush was set up and maintained throughout the clinical procedure.During analysis, the main coil was found to be kinked and stretched.The main coil was returned inside the microcatheter.The suture of the main coil was found to be damaged.The coil delivery wire was noted to be broken/fractured near the detachment zone.The microcatheter was flushed and 0,0158¿ patency mandrel was advanced through, the mandrel got stuck approximately 97cm from the hub.The shaft was cut, and there was difficulty in removing the main coil.The reported coil introducer sheath friction and coil in catheter friction could not be replicated during device analysis due to condition of the returned device; however, the analysis results are consistent with the reported event.An assignable cause of procedural factors will be assigned to reported coil introducer sheath friction and coil in catheter friction as the 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.The reported main coil prematurely detached/separated during use was not confirmed during the analysis as the delivery wire was broken/fractured near the detachment zone, hence an assignable cause of not confirmed will be assigned.An assignable cause of procedural factors will be assigned to the as analyzed coil delivery wire broken/fractured during use , main coil kinked/bent , main coil stretched, and main coil suture 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.
Event or Problem Description
It was reported that during procedure there was resistance when the subject coil was advanced through the introducer sheath and shaft of microcatheter and the subject coil got prematurely detached within the microcatheter during advancement.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET XXL 360 20MM 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: 21712988
• Report Number: 3008881809-2025-00168
• Device Sequence Number: 4514919
• Product Code: HCG
• UDI-Device Identifier: 07613327128345
• UDI-Public: (01)07613327128345(17)270213(10)24774263
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup
• Report Date (Section B): 05/15/2025

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: M0036182050
• Device Lot Number: 24774263
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2025
• Supplement Date Received by Manufacturer: 04/23/2025
• Initial Report FDA Received Date: 03/27/2025
• Supplement Report FDA Received Date: 05/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2024
• 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 1018 MICROCATHETER (STRYKER).
• Patient Sex: Unknown