MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 4MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035424080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the microcatheter was inserted into the aneurysm and the subject coil was inserted into the microcatheter.The physician detached the subject coil and pulled the delivery wire but the subject coil came out with the delivery wire.When the physician attempted to reinsert the subject coil into the aneurysm, it fractured inside the microcatheter.The microcatheter was removed as the subject coil was jammed inside and could not be retrieved.The physician replaced both devices with new devices and continued the procedure without clinical consequences to the patient.
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.The subject device is not available; therefore, visual testing as well as functional testing cannot be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.It was reported that after a detachment attempt, the delivery wire was pulled back, but the coil had not successfully detached and was pulled back into the microcatheter.When attempting to re-insert the coil, it fractured and was removed with the microcatheter.An assignable cause of undeterminable will be assigned to the reported events of 'main coil failed/unable to detach', 'coil jammed', main coil broken/fractured during use' as the product was not returned and review and analysis of all available information fails to indicate an assignable cause or probable assignable cause.
Event or Problem Description
It was reported that during the procedure, the microcatheter was inserted into the aneurysm and the subject coil was inserted into the microcatheter.The physician detached the subject coil and pulled the delivery wire but the subject coil came out with the delivery wire.When the physician attempted to reinsert the subject coil into the aneurysm, it fractured inside the microcatheter.The microcatheter was removed as the subject coil was jammed inside and could not be retrieved.The physician replaced both devices with new devices and continued the procedure without clinical consequences to the patient.
Event or Problem Description
It was reported that during the procedure, the microcatheter was inserted into the aneurysm and the subject coil was inserted into the microcatheter.The physician detached the subject coil and pulled the delivery wire but the subject coil came out with the delivery wire.When the physician attempted to reinsert the subject coil into the aneurysm, it fractured inside the microcatheter.The microcatheter was removed as the subject coil was jammed inside and could not be retrieved.The physician replaced both devices with new devices and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H2 - follow-up, type - updated.H3 device evaluated by mfg ¿updated.H6 type of investigation - method code grid - updated.H6 investigation findings - results code grid - updated.H6 investigation conclusions - conclusion code grid - 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 device was returned with the microcatheter.The coil delivery wire was found to be severely kinked/bent.The main coil was found to be kinked/bent.The main coil was found to be stretched.The main coil was found to be detached/separated from the delivery wire.The functional test for main coil failed unable to detach could not be replicated as the main coil was returned already detached.However, the analysis results are consistent with the reported event.Main coil broken/fractured was not confirmed during the analysis.Coil jammed was not confirmed as the main coil was not returned jammed into the microcatheter.However, the analysis results are consistent with the 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.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.It was reported that after a detachment attempt, the delivery wire was pulled back but the coil had not successfully detached and was pulled back into the microcatheter.When attempting to re-insert the coil, it fractured and was removed with the microcatheter.Based on the returned device inspection, it is likely that the coil was partially detached electrolytically and then physically separated at the detachment zone when the delivery wire was pulled back.The device was confirmed to be in good condition prior to use and appears to have been used per the dfu.The anatomy was noted to be severely tortuous.An assignable cause of procedural factors will be assigned to the reported events of, 'main coil failed/unable to detach', 'coil jammed' and to the analyzed codes 'main coil stretched', 'main coil kinked/bent' and 'main coil prematurely detached/separated during use' as the issue is associated with a product that meets stryker design and manufacture specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of not confirmed will be assigned to the reported code 'main coil broken/fractured during use' as the returned device inspection confirmed the coil separated at the detachment zone.The main coil was not broken/fractured.An assignable cause of handling damage will be assigned to the analyzed code 'coil delivery wire kinked/bent'.The issue is due to handling of the product or portion of the product during the clinical procedure, upon removal of the product from the packaging, or preparation of the product prior to use.

• Brand Name: TARGET 360 ULTRA 4MM X 8CM
• 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: 20961970
• Report Number: 3008881809-2024-00608
• Device Sequence Number: 12823073
• Product Code: HCG
• UDI-Device Identifier: 04546540675927
• UDI-Public: (01)04546540675927(17)270916(10)25191076
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,Followup,Followup
• Report Date (Section B): 06/02/2025

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: M0035424080
• Device Lot Number: 25191076
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/30/2024
• Supplement Date Received by Manufacturer: 02/10/2025; 05/09/2025
• Initial Report FDA Received Date: 12/18/2024
• Supplement Report FDA Received Date: 03/03/2025; 06/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/17/2024
• 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).
• Patient Sex: Unknown