MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET XL 360 SOFT 12MM X 45CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0036121240
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported during the procedure that when the subject coil was repositioned, it prematurely detached inside the catheter while retracting.The physician replaced both devices and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added h3 device evaluated by mfg ¿updated h3 summary attached - updated d4 expiration date - added d9 product available to stryker ¿ updated d9 returned to manufacturer on ¿updated the returned product was confirmed to be the product reported in the complaint.During visual inspection, the subject coil delivery wire was noted to be kinked/bent.The main coil was seen broken/fractured, stretched and removed from the microcatheter.The suture was found damaged.Functional inspection was not performed as visual inspection results proved sufficient.Due to the automated manufacturing execution system there are controls in the manufacturing process to ensure the product met specifications upon release.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 product was returned, and the reported event was not confirmed during analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information received stated that the device was inspected prior to use and no issue was noticed.After detachment, no portion of the coil protruded out of the aneurysm or into the parent vessel.The device was returned for analysis and the coil delivery wire was found to be kinked/bent, and the main coil was found to be broken/fractured, stretched and removed from the microcatheter.In the case of this complaint it is most likely that when the device encountered difficulties during the clinical procedure, the damage caused to the delivery wire and main coil was due to handling and manipulation of the device.The as analyzed events of main coil broken/fractured during use, main coil stretched and main coil suture damaged will be assigned with an assignable cause of procedural factors as this complaint appears 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 factors during use.An assignable cause of handling damage will be assigned to the as analyzed event of coil delivery wire kinked/bent as the issue is associated with handling of the device during the clinical procedure, upon removal of the device from the packaging, or preparation of the device prior to use.An assignable cause of not confirmed will be assigned to the as reported event f main coil prematurely dethatched/separated during use as the coil was found to be still attached during device analysis.
Event or Problem Description
It was reported during the procedure that when the subject coil was repositioned, it prematurely detached inside the catheter while retracting.The physician replaced both devices and the procedure was completed successfully with no clinical consequences to the patient.

• Brand Name: TARGET XL 360 SOFT 12MM X 45CM
• 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: 15581177
• Report Number: 3008881809-2022-00504
• Device Sequence Number: 5978604
• Product Code: HCG
• UDI-Device Identifier: 04546540711533
• UDI-Public: 04546540711533
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 11/30/2022

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: 02/23/2025
• Device Model Number: M0036121240
• Device Catalogue Number: M0036121240
• Device Lot Number: 23501180
• 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: 09/21/2022
• Supplement Date Received by Manufacturer: 11/17/2022
• Initial Report FDA Received Date: 10/11/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/25/2022
• 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 SL-10 MICROCATHETER (STRYKER); EXCELSIOR SL-10 MICROCATHETER (STRYKER)
• Patient Age: 66 YR
• Patient Sex: Female