MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 4.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413045
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis, and it was discovered that the subject coil delivery wire was found to be broken/fractured and the procedure was completed successfully.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the subject coil was returned jammed inside the microcatheter.The coil delivery wire proximal end was seen to be kinked/bent.The coil delivery wire was seen to be kinked/bent.The coil delivery wire was seen to be broken/fractured.The main coil was seen to be stretched.During the functional inspection, after soaking it in warm water, the subject device was removed from the microcatheter without 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 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.It was reported that the subject coil got stuck in the microcatheter.No additional information was received for this complaint.During analysis, it is possible that continuous flush may not have been administered during the case as evidenced by the dried procedural fluid noted in the microcatheter.This could have resulted in the reported jamming in the microcatheter and damage to the coil when advancing it against resistance.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the as reported and as analyzed 'coil jammed' as well as the as analyzed 'coil delivery wire broken/fractured during use' and 'main coil stretched' since these issues are associated with a product that met stryker design and manufacturing 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 handling damage will be assigned to the as analyzed 'coil proximal contact kinked/bent' and 'coil delivery wire kinked/bent' since these issues are most likely due to handling of the product during the clinical procedure.

• Brand Name: TARGET TETRA 3.0MM X 4.5CM
• 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: 23700805
• Report Number: 3008881809-2025-00678
• Device Sequence Number: 21505696
• Product Code: HCG
• UDI-Device Identifier: 07613327578645
• UDI-Public: (01)07613327578645(17)270616(10)24991302
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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
• Report Date (Section B): 12/02/2025

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
• Device Catalogue Number: TG5413045
• Device Lot Number: 24991302
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2025
• Initial Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/17/2024
• 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: MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown