MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 NANO 1MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421020
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/02/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a coil embolization procedure was performed to treat cerebral aneurysm in a-com.While advancing the subject coil, physician felt resistance in the middle of the microcatheter.He was unable to advance or retrieve the subject coil and while doing so, the subject coil got prematurely detached.The subject coil was removed safely from the patients vascular anatomy.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/microscopic inspection: the main coil was seen to be detached.The main coil was seen to be kinked/bent and stretched.The coil delivery wire was seen to be kinked/bent.The coil introducer sheath was intact.Functional inspection: due to the detachment of the main coil, a functional inspection was not possible.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 reported event 'coil in catheter friction' and 'coil introducer sheath friction' could not be confirmed; however, the analysis results are consistent with the reported event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was analyzed.The coil delivery wire was found to be kinked/bent.The main coil was found to be kinked/bent and stretched, and main coil was found to be prematurely detached/separated during use.An assignable cause of procedural factors will be assigned to the as reported 'coil introducer sheath friction, coil in catheter friction, as reported/ as analyzed 'main coil prematurely detached/separated during use, and as analyzed 'main coil kinked/bent' and 'main coil stretched', 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.An assignable cause of 'handling damage' will be assigned to the as analyzed 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product upon removal of the product from the packaging.
Event or Problem Description
It was reported that a coil embolization procedure was performed to treat cerebral aneurysm in a-com.While advancing the subject coil, physician felt resistance in the middle of the microcatheter.He was unable to advance or retrieve the subject coil and while doing so, the subject coil got prematurely detached.The subject coil was removed safely from the patients vascular anatomy.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET 360 NANO 1MM X 2CM
• 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: 15318385
• Report Number: 3008881809-2022-00418
• Device Sequence Number: 5505076
• Product Code: HCG
• UDI-Device Identifier: 04546540697967
• UDI-Public: 04546540697967
• 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): 10/28/2022

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: 03/07/2025
• Device Model Number: M0035421020
• Device Catalogue Number: M0035421020
• Device Lot Number: 23518578
• 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: 08/02/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 08/30/2022
• Supplement Report FDA Received Date: 10/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/09/2022
• 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: MICROCATHETER (UNKNOWN)
• Patient Sex: Unknown