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	03/26/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil detached prematurely inside the microcatheter during the procedure.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that the subject coil detached prematurely inside the microcatheter during the procedure.The subject device was replaced, and the procedure was completed successfully.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) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection the device was returned inside the microcatheter.The main coil was separated from the delivery wire due to a break to the platinum iridium wire.The remaining coil delivery wire was not returned.During functional test the microcatheter was flushed, and the 0¿0158 patency mandrel was advanced through, approximately 100 cm from the strain relief it was blocked by a coil, therefore it was cut to remove the main coil, which was damaged and stretched during this process.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 device 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 prematurely detached inside the microcatheter during the procedure.Additional information provided by the customer indicated that 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.While advancing the coil the operator proceeded slowly and carefully.There was no resistance while moving the coil.Resistance was encountered at the shaft of the microcatheter.The product was returned for analysis, and the coil was found to be inside the microcatheter.The main coil was separated from the delivery wire due to a break to the platinum iridium wire and the remaining coil was not returned.The microcatheter was flushed, and a 0.0158" patency mandrel was advanced through it.Approximately 100 cm from the strain relief, advancement was obstructed by a coil.So, the catheter was cut to remove the main coil, which was damaged and stretched during the process.An assignable cause of procedural factors will be assigned to as reported events: ¿coil jammed¿ and ¿main coil prematurely detached /separated during use¿ as well as analyzed events: ¿main coil prematurely detached/separated during use¿ and ¿coil jammed¿ 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.

• 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: 21870022
• Report Number: 3008881809-2025-00219
• Device Sequence Number: 4221566
• Product Code: HCG
• UDI-Device Identifier: 07613327128383
• UDI-Public: (01)07613327128383(17)251214(10)24069997
• 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): 06/23/2025

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: 12/14/2025
• Device Catalogue Number: M0036181450
• Device Lot Number: 24069997
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/09/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2025
• Supplement Date Received by Manufacturer: 05/30/2025
• Initial Report FDA Received Date: 04/19/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2022
• 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: CARNELIAN SI MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown