MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035442040
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
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 only returned, the main coil was found to be detached and not returned.The detachment seems to be mechanical, and the coil delivery wire was found to be kinked/bent.Functional test was unable to perform due to coil damage.The reported can be confirmed as the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation, based on the damage 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.Additional information provided by the customer that no damage noted to the packaging prior to opening the packaging.Also, device prepared for use as per the directions for use and continuous flush was set up and maintained throughout the clinical procedure.The patient¿s anatomy was described as moderately tortuous.The device delivery wire was not returned, the coil had been mechanically detached from the delivery wire and the delivery wire was kinked.It is probable that the delivery was kinked, and the main coil was prematurely detached inside the microcatheter due to the reported coil jamming.An assignable cause of procedural factors will be assigned to the reported ¿coil jammed¿ and to the analyzed ¿coil delivery wire kinked/bent¿ and ¿main coil prematurely detached/separated during use¿, as the issue is associated with a product that meets stryker design and manufacture specifications and was used in according with the dfu but due to procedural and/or anatomical factors during use, the product performance was limited.
Event or Problem Description
Analysis of the returned device found the main coil prematurely detached/separated during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 2MM X 4CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA ; EI NA
• MDR Report Key: 12544238
• Report Number: 3008881809-2021-00401
• Device Sequence Number: 3420128
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• 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: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2021

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: 11/02/2023
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22541438
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Initial Report FDA Received Date: 09/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1