MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 3MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035423100
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the main coil was seen to be kinked/ bent and detached from the delivery wire.The delivery wire was seen to be kinked/bent and the introducer sheath was intact.Dimensional inspection confirmed the main coil dimensions were within specification.A functional test for the reported 'coil in catheter friction' could not be completed as the main coil was detached.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 event 'coil in catheter friction' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The main coil was found to be detached/separated and kinked/bent.The coil delivery wire was found to be kinked/bent 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.Therefore, an assignable cause of procedural factors will be assigned to the as reported code 'coil in catheter friction' and to the as analyzed codes 'main coil detached/separated during use' and 'main coil kinked/bent'.An assignable cause of handling damage will be assigned to the as analyzed code '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.
Event or Problem Description
The coil (subject device) was returned for analysis and it was discovered that the subject coil had prematurely detached/separated during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 ULTRA 3MM 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: 15796600
• Report Number: 3008881809-2022-00574
• Device Sequence Number: 19969931
• Product Code: HCG
• UDI-Device Identifier: 04546540675903
• UDI-Public: 04546540675903
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/15/2022

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: 02/25/2025
• Device Model Number: M0035423100
• Device Catalogue Number: M0035423100
• Device Lot Number: 23511637
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/24/2022
• Initial Report FDA Received Date: 11/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2022
• 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: MARVEL MICROCATHETER (TOKAI MEDICAL).
• Patient Age: 76 YR
• Patient Sex: Male