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	09/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During coil embolization of superior mesenteric artery for gastrointestinal bleeding, the subject coil had resistance while advancing past the introducer sheath.The physician successfully delivered the subject coil into the lesion.When detachment was attempted, the subject coil failed to detach.When the physician attempted to remove the subject coil along with the microcatheter, the subject coil detached prematurely into the intended vessel.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
During coil embolization of superior mesenteric artery for gastrointestinal bleeding, the subject coil had resistance while advancing past the introducer sheath.The physician successfully delivered the subject coil into the lesion.When detachment was attempted, the subject coil failed to detach.When the physician attempted to remove the subject coil along with the microcatheter, the subject coil detached prematurely into the intended vessel.The procedure was completed successfully with no clinical consequences to the patient.
Additional Manufacturer Narrative
H4 manufacturing date ¿ added.D4 expiration date ¿ added.The subject device was not returned; therefore, visual and functional testing as well as physical analysis cannot be performed.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.Due to the automated manufacturing execution 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.Additional information provided by the customer indicated that the device was confirmed to be in good condition during preparation/prior to use on the patient and was prepared as per the dfu, continuous flush was set up and maintained throughout the clinical procedure, the patient's anatomy was very tortuous, the tapered distal end of the introducer sheath was firmly seated in the hub of the microcatheter, the rhv was adequately tightened while the introducer sheath was in the hub (not over/under-tightened) and was opened enough to allow passage of the device through without damage, no torque was given where advancing the delivery wire, and the coil was advanced slowly and gently without applying excessive force.Since the detached coil was placed in the treatment area, no medical intervention was required to remove it.While there are a number of potential causes for the reported issue, because review of available information failed to identify a definitive cause and the device was not returned for analysis, an assignable cause of undeterminable was assigned to the as reported events main coil prematurely detached/separated during use and coil introducer sheath friction.H3 other text : the device is not available to the manufacturer.

• 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
• 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: 15657911
• Report Number: 3008881809-2022-00522
• Device Sequence Number: 5715486
• 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: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2022

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: 02/20/2025
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 23496461
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 11/18/2022
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2022
• 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: CARNELIAN MARVEL MICROCATHETER (TOKAI MEDICAL); CARNELIAN MARVEL MICROCATHETER (TOKAI MEDICAL); INZONE DETACHMENT SYSTEM (STRYKER); INZONE DETACHMENT SYSTEM (STRYKER)
• Patient Sex: Unknown