MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 7MM X 20CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035477200
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the medical procedure, the subject coil was difficult to advance through the microcatheter.A slight kink was noticed on the subject coil delivery wire.Physician continued to advance the subject coil but was unsuccessful.He decided to remove the subject coil and when it was pulled, the subject coil got detached from the pusher wire inside the catheter.The subject coil was removed along with the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
D4: expiration date - added.D9: product available to stryker ¿ updated.D9: returned to manufacturer on ¿updated.H3: summary attached - updated.H3: device evaluated by mfg ¿updated.H4: manufacturing date- added.Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During visual  inspection, the coil delivery wire was found to be kinked/bent in multiple areas.The main coil was found to be broken off the coil delivery wire.The main coil was not returned.  during functional inspection, main coil prematurely detached/separated inside patient functional test was undeterminable as the main coil was not returned.Coil in catheter friction was unable to perform the test as the main coil was found to be broken/fractured and not returned.Coil delivery wire kinked/bent was confirmed during visual inspection.  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 'main coil prematurely detached/separated during use' was undeterminable as the main coil was not returned.The reported 'coil in catheter friction' could not be confirmed; however, the analysis results are consistent with the reported event.The reported 'coil delivery wire kinked/bent' was confirmed during the analysis.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 broken off the delivery wire and main coil was not returned.The coil delivery wire was found to be kinked/bent.An assignable cause of 'undeterminable' will be assigned to the 'main coil prematurely detached/separated during use' as the issue was not confirmed during the analysis.An assignable cause of procedural factors will be assigned to the 'coil in catheter friction' and 'main coil broken/fractured during use' as these defects appear to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.An assignable cause of handling damage will be assigned to the 'coil delivery wire kinked/bent' since this issue is associated with handling of the device during the clinical procedure.
Event or Problem Description
It was reported that during the medical procedure, the subject coil was difficult to advance through the microcatheter.A slight kink was noticed on the subject coil delivery wire.Physician continued to advance the subject coil but was unsuccessful.He decided to remove the subject coil and when it was pulled, the subject coil got detached from the pusher wire inside the catheter.The subject coil was removed along with the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 SOFT 7MM X 20CM
• 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: 16095816
• Report Number: 3008881809-2023-00005
• Device Sequence Number: 6651660
• Product Code: HCG
• UDI-Device Identifier: 04546540676573
• UDI-Public: 04546540676573
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/16/2023

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: 06/27/2024
• Device Model Number: M0035477200
• Device Catalogue Number: M0035477200
• Device Lot Number: 22991193
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/19/2023
• Initial Report FDA Received Date: 01/04/2023
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2021
• 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: HEADWAY MICROCATHETER (MICROVENTION).
• Patient Sex: Unknown