MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 3.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412035
Medical Device Problem Codes	Device Misassembled During Manufacturing /Shipping (2912); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the position of the radiopacity marker on the subject coil seemed misplaced.The subject coil seems to be more ahead of the microcatheter.The procedure was completed successfully using the subject device.No further information is available.
Additional Manufacturer Narrative
This is 2 of 3 mdrs (2nd mdr).H3 device evaluated by mfg ¿updated.F10 / h6 medical device problem code - device code grid - updated.Section b1 adverse event/product problem - corrected - no product problem.Section h1 type of reportable event - corrected - no malfunction.Due to the automated mes (manufacturing execution system), there are controls in the manufacturing process to ensure the product met specifications upon release.A lot history review was completed, and no issues were identified.On review of the device history record (dhr) for this lot, it was determined that scrap that occurred during the manufacturing of this lot was not related to this complaint.Additionally, a component lot history review was completed on the delivery wire lots associated with this unit, and no issues were identified.During visual inspection, the coil delivery wire was seen to be kinked/bent in multiple locations.The ro marker (radiopacity marker) was present on the delivery wire.The main coil was implanted and was not returned with the delivery wire.A functional inspection was not applicable, as the reported complaint is a dimensional issue.The reported complaint was not confirmed based on analysis.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 position of the radiopacity marker on the subject device seemed to be misplaced as the coil appeared to be more ahead of the microcatheter than usual.The procedure itself was completed successfully using the subject device.Additional information provided by the customer indicated that no anomalies were noted to the packaging/device prior to use on the patient, the device was prepared for use as per the directions for use, continuous flush was set up and maintained throughout the clinical procedure, the tortuosity of the patient's anatomy was average, and the coil was advanced slowly and carefully without excessive force.The device was returned for analysis, and it was noted that the coil delivery wire was kinked in multiple locations along its length.The ro marker was present on the delivery wire.The main coil was not returned with the delivery wire as it had been electrolytically detached and implanted in the patient as evidenced by the dissolved detachment zone.One potential cause for the reported event is the distance between the proximal marker of the delivery wire and the detachment zone is too long.The measurements that set this specification could not be taken post detachment due to the absence of the detachment zone.While the reported complaint could not be confirmed through direct measurement of the returned unit, a review of the manufacturing records indicates that the device was manufactured to specification.Due to the return condition of the device this could not be confirmed through dimensional inspection.An assignable cause of undeterminable will be assigned to the as reported 'ro marker band misaligned'.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, a cause of undeterminable was assigned.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this issue is associated with 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.
Event or Problem Description
It was reported the position of the radiopacity marker on the subject coil seemed misplaced.The subject coil seems to be more ahead of the microcatheter.The procedure was completed successfully using the subject device.No further information is available.

• Brand Name: TARGET TETRA 2.0MM X 3.5CM
• 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: 21988685
• Report Number: 3008881809-2025-00264
• Device Sequence Number: 4478009
• Product Code: HCG
• UDI-Device Identifier: 07613327578584
• UDI-Public: (01)07613327578584(17)270513(10)24949751
• 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): 06/13/2025

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: TG5412035
• Device Lot Number: 24949751
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/17/2025
• Supplement Date Received by Manufacturer: 06/09/2025
• Initial Report FDA Received Date: 05/08/2025
• Supplement Report FDA Received Date: 06/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/14/2024
• 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 (STRYKER); TARGET COIL (STRYKER)
• Patient Sex: Unknown