MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 3CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421030
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject coil encountered strong resistance at the hub of the microcatheter.It was replaced with another coil, but resistance was also noted with this coil.The coil was replaced the third time but it still could not be advanced inside the catheter.Upon removal, the physician confirmed that the subject coil was prematurely deployed inside the microcatheter and was stretched at the proximal section.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.It was reported that during the procedure, the subject coil encountered strong resistance at the hub of the microcatheter.Upon removal, it was confirmed that the subject coil was prematurely deployed inside the microcatheter and was stretched at the proximal section.It was replaced with another coil, but resistance was also noted with this coil.The coil was replaced for the third time, but still it could not be advanced inside the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.Visual and functional inspection were not performed because the product was not returned for investigation.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 indicated that there was friction or resistance while the coil was advancing the introducer sheath.The friction or resistance were felt at the hub.The devices were prepared for use as per the directions for use.The devices were confirmed to be in good condition during preparation/prior to use on the patient.Continuous flush was set up and maintained throughout the clinical procedure.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 will be assigned to this complaint.
Event or Problem Description
It was reported that during the procedure, the subject coil encountered strong resistance at the hub of the microcatheter.It was replaced with another coil, but resistance was also noted with this coil.The coil was replaced the third time but it still could not be advanced inside the catheter.Upon removal, the physician confirmed that the subject coil was prematurely deployed inside the microcatheter and was stretched at the proximal section.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.It was reported that during the procedure, the subject coil encountered strong resistance at the hub of the microcatheter.Upon removal, it was confirmed that the subject coil was prematurely deployed inside the microcatheter and was stretched at the proximal section.It was replaced with another coil, but resistance was also noted with this coil.The coil was replaced for the third time, but still it could not be advanced inside the catheter.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 1MM 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: 13333684
• Report Number: 3008881809-2022-00033
• Device Sequence Number: 1595011
• Product Code: HCG
• UDI-Device Identifier: 04546540697974
• UDI-Public: 04546540697974
• 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): 04/21/2022

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: 10/06/2023
• Device Model Number: M0035421030
• Device Catalogue Number: M0035421030
• Device Lot Number: 22492894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/27/2021
• Supplement Date Received by Manufacturer: 03/23/2022
• Initial Report FDA Received Date: 01/24/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/07/2020
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).; INZONE DETACHMENT SYSTEM (STRYKER).; TARGET COILS (STRYKER).
• Patient Age: 74 YR
• Patient Sex: Female