MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 STANDARD 14MM X 50CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036101450
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the subject coil detached during the procedure when an attempt was made to retract it into the microcatheter to reposition the subject coil.No clinical consequences reported to the patient.
Event or Problem Description
It was reported that the subject coil detached during the procedure when an attempt was made to retract it into the microcatheter to reposition the subject coil.No clinical consequences reported to the patient.
Additional Manufacturer Narrative
The automated manufacturing execution system (mes) has controls in the manufacturing process to ensure the product met specifications upon release.The device was returned together with un-known device.The main coil was found to be kinked/bent and detached/separated.Additionally, the core delivery wire was found to be kinked/ bent.The functional testing could not be performed due to the condition of the returned device.The reported main coil prematurely detached/separated during use was confirmed during the analysis.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 returned device was analyzed.The main coil was found to be prematurely detached/separated and kinked/bent.The coil delivery wire was found to be kinked/bent.An assignable cause of procedural factors will be assigned to the reported and as analyzed ¿main coil prematurely detached/separated during use and to ¿main coil kinked/bent¿, as the issues are associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.A probable cause of handling damage was assigned to the ¿coil delivery wire kinked/bent¿ as the defect appears to be associated with handling of the product or portion of the product during the procedure.

• Brand Name: TARGET XL 360 STANDARD 14MM X 50CM
• 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: 14603170
• Report Number: 3008881809-2022-00274
• Device Sequence Number: 6146738
• Product Code: HCG
• UDI-Device Identifier: 04546540711298
• UDI-Public: 04546540711298
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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,Followup
• Report Date (Section B): 07/01/2022

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: 11/07/2024
• Device Model Number: M0036101450
• Device Catalogue Number: M0036101450
• Device Lot Number: 23283715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/26/2022
• Supplement Date Received by Manufacturer: 06/24/2022
• Initial Report FDA Received Date: 06/06/2022
• Supplement Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/09/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Unknown