MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 STANDARD 12MM X 30CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035461230
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available to the manufacturer.
Event or Problem Description
It was reported that during the left internal carotid artery (ica) aneurysm procedure, physician prepared and inserted the subject coil.While adjusting the position of the subject coil, it detached unexpectedly half in the microcatheter and half in the aneurysm.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) there are controls in the manufacturing process to ensure the product met specifications upon release.During the visual inspection: the main coil was seen to be detached/separated.The main coil was intact.The coil delivery wire was not returned.The coil introducer sheath was not returned.Functional inspection: not required 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 event - main coil prematurely detached/separated during use was confirmed during analysis.The device was analyzed.The coil delivery wire was found to be missing.The main coil was found to be intact, but to be prematurely detached/separated.Additional information provided by the customer indicated that the device was prepared according to directions for use.After inserting the coil into the aneurysm and adjusting its position, the operator discovered that the coil had unexpectedly detached.It is probable that the coil was detached during position adjustment due to the excessive force. an assignable cause of procedural factors will be assigned to the - main coil prematurely detached/separated during use, as the defects appears to be associated with a product that met stryker design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural factors during use.
Event or Problem Description
It was reported that during the left internal carotid artery (ica) aneurysm procedure, physician prepared and inserted the subject coil.While adjusting the position of the subject coil, it detached unexpectedly half in the microcatheter and half in the aneurysm.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.

• Brand Name: TARGET 360 STANDARD 12MM X 30CM
• 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: 15993486
• Report Number: 3008881809-2022-00628
• Device Sequence Number: 14978249
• Product Code: HCG
• UDI-Device Identifier: 07613252192503
• UDI-Public: 07613252192503
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 01/17/2023

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: M0035461230
• Device Catalogue Number: M0035461230
• Device Lot Number: 23428704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/19/2022
• Supplement Date Received by Manufacturer: 12/21/2022
• Initial Report FDA Received Date: 12/16/2022
• Supplement Report FDA Received Date: 01/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: 6F GUIDE CATHETER (UNKNOWN); SL-10 MICROCATHETER ( STRYKER); SYNCHRO GUIDEWIRE (STRYKER)
• Patient Age: 60 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Race: Asian