MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 1.5MM X 2.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5411520
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection, the coil delivery wire was retrieved during microcatheter investigation.The coil delivery wire was seen to be kinked/bent.The coil delivery wire proximal contact was seen to be kinked/bent.The coil delivery wire was seen to be broken/fractured near the detachment zone.The main subject and introducer sheath were not returned.The functional inspection was not carried out due to the damage noted to the device.The reported complaint was confirmed based on the damage noted to the device during device inspection.The reported detachment failure could not be replicated but 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.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 after multiple attempts to insert the subject coil, it got stuck in the tip of the microcatheter.Both devices were removed from the body and replaced with new ones, and the procedure was completed successfully.The device was returned for analysis, and it was noted that the subject coil had separated from the delivery wire due to a break at the detachment zone.The subject coil was not returned.An assignable cause of procedural factors will be assigned to the as reported code, ' coil in catheter friction' and the as analyzed code 'main coil prematurely detached/separated during use'.An assignable cause of handling damage will be assigned to the as analyzed codes, 'coil proximal contact kinked/bent' and 'coil delivery wire kinked/bent' because the damage appears to be associated with handling of the product or portion of the product during the procedure / upon removal of the product from the packaging / preparation of the product prior to use.This 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 (dfu), but performance was limited due to procedural factors during use.
Event or Problem Description
Analysis of the returned device found that the subject coil detached prematurely during use.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully.

• Brand Name: TARGET TETRA 1.5MM X 2.0CM
• 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: 23375704
• Report Number: 3008881809-2025-00580
• Device Sequence Number: 8899713
• Product Code: HCG
• UDI-Device Identifier: 07613327580099
• UDI-Public: (01)07613327580099(17)270708(10)25030606
• 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): 10/23/2025

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: TG5411520
• Device Lot Number: 25030606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2025
• Initial Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2024
• 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