MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035475150
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device is unavailable to manufacturer.
Event or Problem Description
It was reported that during procedure, it was a difficulty and hooky to insert and advance the subject coil.When pulling back the sleeve, the subject coil is then finally torn off.There were no clinical consequences reported to the patient due to this event.No further information available at this time.
Additional Manufacturer Narrative
D9/h3 product available to stryker ¿ updated.D9 returned to manufacturer on ¿updated.H3 device evaluated by mfg ¿updated.H3 summary attached - updated.Section b1 adverse event/product problem - corrected - no product proble.Section h1 type of reportable event - corrected - no malfunction.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual inspection of the returned device revealed the coil delivery wire was found to be kinked/bent, the coil proximal contact wire was found to be broken/fractured and the main coil was found to be stretched.The reported ¿main coil broken/fractured during use¿ was not confirmed during the analysis.The reported ¿main coil difficulty inserting¿ could not be confirmed; however, the analysis results are consistent with the reported event.The reported ¿main coil friction¿ 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.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.An assignable cause of ¿not confirmed¿ will be assigned to the reported ¿main coil broken/fractured during use¿ as the issue was not confirmed during the analysis.An assignable cause of ¿procedural factors¿ will be assigned to the reported ¿main coil difficulty inserting, ¿main coil friction¿ and an assignable cause ¿main coil stretched¿ 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 an assignable cause ¿coil delivery wire kinked/bent' and ¿coil proximal contact wire broken/fractured¿ since this issue is associated with handling of the device during the clinical procedure.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.
Event or Problem Description
It was reported that during procedure, it was a difficulty and hooky to insert and advance the subject coil.When pulling back the sleeve, the subject coil is then finally torn off.There were no clinical consequences reported to the patient due to this event.No further information available at this time.

• Brand Name: TARGET 360 SOFT 5MM X 15CM
• 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: 15845605
• Report Number: 3008881809-2022-00585
• Device Sequence Number: 12489926
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2023

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: 04/11/2025
• Device Model Number: M0035475150
• Device Catalogue Number: M0035475150
• Device Lot Number: 23587427
• 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: 11/14/2022
• Supplement Date Received by Manufacturer: 01/31/2023
• Initial Report FDA Received Date: 11/22/2022
• Supplement Report FDA Received Date: 01/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/13/2022
• 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
• Patient Sex: Unknown