MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035474100
Medical Device Problem Code	No Visual Prompts/Feedback (4021)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during pcoma aneurysm procedure, resistance encountered when advancing and retracting the subject coil.The subject coil could not be seen under dsa (digital subtraction angiography).When the operator withdrew the subject coil it was found stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during pcoma aneurysm procedure, resistance encountered when advancing and retracting the subject coil.The subject coil could not be seen under dsa (digital subtraction angiography).When the operator withdrew the subject coil it was found stretched.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) system 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 severely kinked/bent, the main coil was found to be stretched, and the device was viewed under fluoroscopy.Main coil stretched functional test was not performed as the defect was confirmed during visual inspection.Also, 'device or device component not visible under fluoroscopy' functional test - this device was sent to fremont to view the device under fluoroscopy and was visible.The reported defect of main coil stretched was confirmed during analysis.The reported main coil friction was confirmed during analysis , possible cause from delivery wire being so damaged, and the reported device or device component not visible under fluoroscopy was not confirmed.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).In addition, 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 device was returned for analysis and the coil was found to be stretched and the coil delivery wire was found to be kinked/bent.Because the device was visible under fluoroscopy in fremont, not confirmed will be added the the reported code 'device or device component not visible under fluoroscopy '.An assignable cause was assigned to the reported and to the analyzed code 'main coil stretched' and 'main coil friction' 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 performance was limited due to procedural factors.Therefore, an assignable cause of procedural factors will be assigned to this complaint.The assignable cause of handling damage will be assigned to the as analyzed '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.The manufacturer has reviewed all information and determined this event no longer meets the requirement of the reportable event for the device in question.

• Brand Name: TARGET 360 SOFT 4MM X 10CM
• 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: 16019866
• Report Number: 3008881809-2022-00638
• Device Sequence Number: 20298276
• Product Code: HCG
• UDI-Device Identifier: 07613252192756
• UDI-Public: 07613252192756
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 02/27/2023

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: 01/06/2024
• Device Model Number: M0035474100
• Device Catalogue Number: M0035474100
• Device Lot Number: 22651307
• 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: 12/12/2022
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 02/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/07/2021
• 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: 6FNAVIE MIDDLE CATHETER (NON-STRYKER); 6FNEURON MAX (NON-STRYKER); ATLAS STENT (STRYKER); ECHELON-10 CATHETER (NON-STRYKER); EV3 COIL (NON-STRYKER); SL10 CATHETER (STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Race: Asian