MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474100
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2024
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 analysis, the main coil was found to be kinked/bent, and stretched.Additionally, the coil delivery wire was kinked/bent, and fractured at the proximal end, likely while inserting it into the power supply device.It is probable that the main coil sustained damage during the procedure due to attempted repositioning.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 it was reported that the doctor attempted to detach the subject coil using a power supply device.After four failed attempts the coil remained attached.Switching to a new power supply device also failed.An assignable cause of procedural factors will be assigned to the as reported main coil failed/unable to detach as well as the as analyzed main coil kinked/bent, coil delivery wire kinked/bent and coil delivery wire broken/fractured during use since these issues appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but performance was limited due to procedural and/or anatomical factors during use.
Event or Problem Description
The device was returned for analysis and the investigation of the device revealed that the coil delivery wire proximal end was broken/fractured.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 4MM 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: 19667692
• Report Number: 3008881809-2024-00296
• Device Sequence Number: 6745422
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K153658
• 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): 07/03/2024

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 Expiration Date: 11/28/2024
• Device Catalogue Number: M0035474100
• Device Lot Number: 23346035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/13/2024
• Initial Report FDA Received Date: 07/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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: INZONE DETACHMENT SYSTEM (STRYKER).
• Patient Age: 73 YR
• Patient Sex: Female