MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.5MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413580
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 inspection, the device was received.The reported lot number was confirmed from the packaging label.The coil delivery wire was seen to be kinked.The main coil was returned partially deployed from the sl-10 microcatheter.The coil was seen to be detached.The main coil was seen to be stretched and the suture damaged.Functional inspection was performed as coil in catheter friction functional test failed, the main coil could not be advanced from the catheter.The sl-10 was flushed, and the delivery wire was advanced slightly before high friction was noted.When the delivery wire was being removed proximally the coil (outside the catheter) did not move.It was noted to be prematurely detached.The reported event is covered in the device direction 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 subject coil couldn't pass through the microcatheter.Additional information provided by the customer indicated that the device was prepared as per the directions for use and there was no damage noted to the packaging during initial inspection and preparation of the device.There was friction/resistance encountered during the procedure through the middle of the microcatheter.The reported coil in catheter friction was confirmed during analysis.Based on the review of all available information, an assignable cause of procedural factors will be assigned to as reported coil in catheter friction and as analyzed codes main coil prematurely detached/separated during use, main coil stretched, main coil suture damage and coil in catheter friction as the complaint appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the directions for use, but performance was limited due to procedural factors during use and an assignable cause of handling damage will be assigned to as analyzed coil delivery wire kinked/bent as this complaint appears to be associated with handling of the product or portion of the product during the procedure.
Event or Problem Description
The coil (subject device) was returned for analysis, and the device investigation revealed that the subject main coil was partially deployed from microcatheter, and the subject main coil was noted to be detached.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 3.5MM X 8.0CM
• 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: 22789744
• Report Number: 3008881809-2025-00443
• Device Sequence Number: 18597632
• Product Code: HCG
• UDI-Device Identifier: 07613327578690
• UDI-Public: (01)07613327578690(17)270728(10)25076052
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/12/2025

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: TG5413580
• Device Lot Number: 25076052
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/29/2024
• 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: SL-10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown