MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XXL 360 8MM X 40CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0036180840
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2023
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 and microscopic inspection, it was seen that the subject coil was returned along with the microcatheter, and it was found to be mechanically detached inside the microcatheter.The coil introducer sheath and the coil delivery wire were not returned, and the main coil was found to be intact.As the subject coil was detached inside the microcatheter, functional testing for friction defect could not be performed and pre-mature detachment was confirmed during visual inspection.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.The reported main coil prematurely detached/separated during use was confirmed during the analysis.The reported coil in catheter friction could not be duplicated; 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.During analysis, the main coil was found to be detached inside the microcatheter and was found to be intact.The coil delivery wire and the coil introducer sheath were not returned.An assignable cause of procedural factors will be assigned to the as reported coil in catheter friction and to as reported/as analyzed main coil prematurely detached/separated during use as this complaint is 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
It was reported that during an embolization procedure, the subject coil got stuck inside the microcatheter.When tried to retrieve the subject coil with a wire, it got pre-maturely detached inside the microcatheter.The subject coil was removed along with the microcatheter.There were no clinical consequences to the patient reported as a result of this event and the procedure was completed successfully with another device.

• Brand Name: TARGET XXL 360 8MM X 40CM
• 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: 18342769
• Report Number: 3008881809-2023-00588
• Device Sequence Number: 8424771
• Product Code: HCG
• UDI-Device Identifier: 07613327466423
• UDI-Public: 07613327466423
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K161429
• 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): 12/18/2023

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: 12/13/2025
• Device Catalogue Number: M0036180840
• Device Lot Number: 24053169
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/15/2022
• 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: EXCELSIOR 1018 MICROCATHETER (STRYKER).
• Patient Sex: Unknown