MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 4.0MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5414010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2025
Type of Reportable Event	Malfunction
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 coil delivery wire was found to be kinked/bent in multiple areas.The main coil was found to be stretched.The main coil suture was seen to be damaged and the main coil was seen to be broken/fractured.A functional test was unable to perform due to damage.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 event could not be replicated during device analysis; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.It was reported that resistance was encountered while advancing the subject coil in the introducer sheath and in the microcatheter shaft and also the subject coil got stuck at the distal tip of the microcatheter.The coil was retrieved with the entire microcatheter and replaced with a new one, and the procedure was completed successfully using the replaced microcatheter.There was no allegation against the microcatheter (unknown type).Additional information provided by the customer indicated that no anomalies were noted to the 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 described as average, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rotating homeostasis valve was opened enough to allow passage of the device through without damage when advancing the coil within the microcatheter, torque was not applied to the delivery wire when operating the coil, and the coil was advanced slowly and carefully without excessive force.During visual inspection of the returned device, the coil delivery wire was found to be kinked/bent in multiple areas and the main coil was found to be stretched and broken with suture damage.Although the reported complaint could not be replicated during device analysis, the analysis results are consistent with the reported event as the damage to the main coil is indicative of a device that was advanced against resistance.It is probable that the subject coil experienced friction and jamming during advancement due to procedural factors during use which resulted in the analyzed defects noted to the device.Based on the review of all available information, an assignable cause of procedural factors will be assigned to the as reported 'coil introducer sheath friction', 'coil in catheter friction' and 'coil jammed' as well as the as analyzed 'main coil stretched', 'main coil suture damage' and 'main coil broken/fractured during use' 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.It is possible that the delivery wire may have been kinked as a result of pushing or pulling the wire against the reported resistance.An assignable cause of handling damage will be assigned to the as analyzed 'coil delivery wire kinked/bent' since this defect is most likely due to handling of the product during the clinical procedure.
Event or Problem Description
The coil (subject device) was returned for analysis, and it was discovered that the main coil (subject device) was broken/fractured during use.The subject device was replaced, and the procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 4.0MM X 10CM
• 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: 21590051
• Report Number: 3008881809-2025-00131
• Device Sequence Number: 8938953
• Product Code: HCG
• UDI-Device Identifier: 07613327578737
• UDI-Public: (01)07613327578737(17)270813(10)25117969
• 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
• Report Date (Section B): 03/12/2025

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: TG5414010
• Device Lot Number: 25117969
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/14/2024
• 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: MICROCATHETER (UNKNOWN).
• Patient Sex: Unknown