MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1.5MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421530
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device not returned for evaluation.
Event or Problem Description
It was reported during the procedure the subject coil would not detach.When the physician re-positioned the subject coil, it deviated from the mass and the proximal end of the delivery wire was broken off.The subject coil was removed and replaced with no clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.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.Additional information provided by the customer indicated that there was no damage noted to the packaging prior to opening the packaging and device was prepared for use as per the directions for use.Also, continuous flush was set up and maintained throughout the clinical procedure.A complaint was reported for the event of the coil delivery wire broken/fractured during use and unexpected movement of device.As the device was not returned the probable reason could not be determined.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, a cause of undeterminable was assigned.
Event or Problem Description
It was reported during the procedure the subject coil would not detach.When the physician re-positioned the subject coil, it deviated from the mass and the proximal end of the delivery wire was broken off.The subject coil was removed and replaced with no clinical consequences to the patient.

• Brand Name: TARGET 360 NANO 1.5MM X 3CM
• 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: 16464712
• Report Number: 3008881809-2023-00098
• Device Sequence Number: 18077014
• Product Code: HCG
• UDI-Device Identifier: 04546540697943
• UDI-Public: 04546540697943
• 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,Followup
• Report Date (Section B): 05/23/2023

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: 01/22/2025
• Device Model Number: M0035421530
• Device Catalogue Number: M0035421530
• Device Lot Number: 23498762
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2023
• Supplement Date Received by Manufacturer: 04/28/2023
• Initial Report FDA Received Date: 03/01/2023
• Supplement Report FDA Received Date: 05/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/24/2022
• 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: CHIKAI-14 CATHETER (ASAHI INTEC); DISTAL ACCESS CATHETER SOFIA SELECT 6FR (TERUMO); GUIDE CATHETER FUBUKI DILATOR SHEATH (ASAHI INTEC); GUIDEWIRE (UNKNOWN); SL-10 CATHETER (STRYKER)
• Patient Sex: Unknown