MAUDE Adverse Event Report: TARGET 360 ULTRA 2MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035422060
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/16/2021
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 coil delivery wire was noted to be severely kinked/bent.The main coil was found to be severely stretched and fractured.The functional testing for the returned device was not performed due to the device condition.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.During the analysis, it was found that the main coil delivery wire noted to be severely kinked/bent.The main coil was found severely stretched and broken/fractured.The as reported coil in catheter friction and main coil failed/unable to detach could not be confirmed; however, the analysis results are consistent with the reported event.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 as reported ar/as analyzed aa, 'main coil stretched' as well as to as analyzed aa, 'main coil broken fractured during use'.An assignable cause of handling damage will be assigned to the as analyzed event of coil delivery wire kinked/bent as it is most likely that the delivery wire kinked due to handling of the device during use.
Event or Problem Description
Analysis of the returned device found that the subject coil was fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 ULTRA 2MM X 6CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• MDR Report Key: 12754467
• Report Number: 3008881809-2021-00470
• Device Sequence Number: 14698778
• Product Code: HCG
• UDI-Device Identifier: 07613252239345
• UDI-Public: 07613252239345
• 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
• Report Date (Section B): 11/04/2021

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: 10/12/2023
• Device Model Number: M0035422060
• Device Catalogue Number: M0035422060
• Device Lot Number: 22485563
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2021
• Initial Report FDA Received Date: 11/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2020
• 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: 6F DISTAL ACCESS CATHETER (UNKNOWN); NEUROFORM EZ STENT (STRYKER); SYNCHRO 2 GUIDEWIRE (STRYKER); XT-17 MICROCATHETER (STRYKER); XT-27 MICROCATHETER (STRYKER)
• Patient Age: 52 YR
• Patient Weight: 65