MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 4MM X 6CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035474060
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3 other text : the device is not available for evaluation.
Event or Problem Description
It was reported during the coil embolization for an unruptured cerebral aneurysm in a-com (the anterior communicating artery), the subject coil was guided using with a stryker catheter, and while repositioning several times to engage with the vessel, a resistance was encountered.Fluoroscopic images showed that proximal of the subject coil seemed to be stretched, so it was operated more carefully and performed the detachment with the marker in the appropriate position, but the subject coil could not be detached.It was removed by the physician with a snare device.The subject coil was replaced, and the procedure was completed successfully with no clinical consequences to the patient.
Event or Problem Description
It was reported during the coil embolization for an unruptured cerebral aneurysm in a-com (the anterior communicating artery), the subject coil was guided using with a stryker catheter, and while repositioning several times to engage with the vessel, a resistance was encountered.Fluoroscopic images showed that proximal of the subject coil seemed to be stretched, so it was operated more carefully and performed the detachment with the marker in the appropriate position, but the subject coil could not be detached.It was removed by the physician with a snare device.The subject coil was replaced, and the procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date - added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device was not available; therefore, a visual inspection as well as a functional evaluation could not be performed.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 complaint could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause and the device was not returned, an assignable cause of undeterminable was assigned to the reported event of main coil friction, main coil stretched, main coil failed/unable to detach, device difficulty engaging target vessel and patient medical or surgical intervention required.

• Brand Name: TARGET 360 SOFT 4MM X 6CM
• 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: 18097634
• Report Number: 3008881809-2023-00538
• Device Sequence Number: 17500054
• Product Code: HCG
• UDI-Device Identifier: 04546540676450
• UDI-Public: 04546540676450
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/10/2025
• Device Catalogue Number: M0035474060
• Device Lot Number: 23583755
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: 12/13/2023
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 12/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/12/2022
• 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: SL-10 CATHETER (STRYKER); SNARE (UNKNOWN)
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown