MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035453080
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an endovascular procedure when delivering the subject coil to its destination, there was resistance inside the microcatheter.The physician started to withdraw the subject coil and felt that there was no any resistance.The subject coil detached from the wire and was partly inside the microcatheter.With a coil pusher the physician was able to get the subject coil to the correct destination.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.
Additional Manufacturer Narrative
H3: the device is not available to the manufacturer.
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 visual/microscopic inspection, the coil delivery wire was found to be kinked/bent.The main coil was found to be detached.The introducer sheath and coil were not returned.Main coil prematurely detached/separated during use functional test not done as the defect was confirmed during visual inspection.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 main coil prematurely detached/separated during use was confirmed during analysis.The device was analyzed and only the delivery wire was returned.Main coil was not returned.The main coil was seen to be prematurely detached.The coil delivery wire was noted to be kinked/bent.An assignable cause of procedural factors will be assigned to the as reported main coil prematurely detached/separated during use and coil in catheter friction ' as these defects appear 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 procedural factors will be assigned to the as analyzed main coil prematurely detached/separated during use as these 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 issue is due to handling of the product or portion of the product during the clinical procedure.
Event or Problem Description
It was reported that during an endovascular procedure when delivering the subject coil to its destination, there was resistance inside the microcatheter.The physician started to withdraw the subject coil and felt that there was no any resistance.The subject coil detached from the wire and was partly inside the microcatheter.With a coil pusher the physician was able to get the subject coil to the correct destination.The procedure was completed successfully.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 3MM X 8CM
• 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: 16861562
• Report Number: 3008881809-2023-00222
• Device Sequence Number: 20179829
• Product Code: HCG
• UDI-Device Identifier: 07613252600442
• UDI-Public: 07613252600442
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/06/2023

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: 08/03/2025
• Device Model Number: M0035453080
• Device Catalogue Number: M0035453080
• Device Lot Number: 23801367
• 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: 04/27/2023
• Supplement Date Received by Manufacturer: 05/31/2023
• Initial Report FDA Received Date: 05/03/2023
• Supplement Report FDA Received Date: 06/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/05/2022
• 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