MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036101240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the physician felt a lot of friction when he tried to deploy the subject coil through the microcatheter.He pulled the microcatheter out und saw the subject coil was detached mechanically at the detachment zone.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
Event or Problem Description
It was reported that during procedure the physician felt a lot of friction when he tried to deploy the subject coil through the microcatheter.He pulled the microcatheter out und saw the subject coil was detached mechanically at the detachment zone.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
A2 age at time of event and unit - added.A3a - patient sex - added.A4 weight and unit - added.D4 expiration date - added.D4 gtin - added.D9 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H4 manufacturing date ¿ added.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/microscopic inspection, the main coil was seen to be detached.Introducer sheath was not returned.Functional inspection was not required.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.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 ''the physician felt a lot friction when he tried to deploy the coil through the microcatheter.He pulled the microcatheter out and saw the coil was detached mechanically at the detachment zone".The device was confirmed to be in good condition prior to use and there is no indication of a use error.The patient anatomy was moderately tortuous.The delivery wire was returned for analysis, and it was confirmed that the coil had separated due to a physical break at the detachment zone.An assignable cause of procedural factors will be assigned to the as reported events main coil prematurely detached/separated during use, coil in catheter friction and to the as analyzed main coil prematurely detached/separated during use.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 XL 360 STANDARD 12MM X 45CM
• 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: 22916502
• Report Number: 3008881809-2025-00471
• Device Sequence Number: 21301855
• Product Code: HCG
• UDI-Device Identifier: 04546540711281
• UDI-Public: (01)04546540711281(17)270421(10)24865049
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 10/16/2025

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 Catalogue Number: M0036101240
• Device Lot Number: 24865049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/20/2025
• Supplement Date Received by Manufacturer: 09/24/2025
• Initial Report FDA Received Date: 08/28/2025
• Supplement Report FDA Received Date: 10/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2024
• 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: MICROCATHETER (UNKNOWN)
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 85 KG