MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 2.0MM X 2.5CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5412025
Medical Device Problem Code	Premature Separation (4045)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/07/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3 other text : the device is not available to the manufacturer.
Event or Problem Description
It was reported that during an endovascular procedure when the subject coil was inserted into the microcatheter, there was resistance.The physician attempted to remove it, but the subject coil was detached prematurely in the catheter.Therefore, the subject coil was removed by cutting off the proximal part of the microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.
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 noted to be kinked.The main coil was seen to be detached and not returned.Main coil prematurely detached/separated during use functional test was 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 main coil prematurely detached/separated during use was confirmed during analysis.The reported coil introducer sheath friction and main coil difficulty insert could not be confirmed as the main coil was not returned.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.The device was prepared for use as per the dfu.There was no damage noted to the packaging prior to opening the packaging.Continues flush was maintained throughout the procedure.The patient¿s anatomy was normal.During analysis, the main coil was seen to be detached and the coil delivery wire was kinked.An assignable cause of procedural factors will be assigned to the as reported 'main coil prematurely detached separated during use¿ 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 undeterminable will be assigned to the as reported coil introducer sheath friction and main coil difficulty inserting as the main coil was not returned and therefor could not be tested.An assignable cause of procedural factors will be assigned to the as analyzed main coil prematurely detached/separated during use 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 defect appears to be associated with handling of the product or portion of the product during preparation.
Event or Problem Description
It was reported that during an endovascular procedure when the subject coil was inserted into the microcatheter, there was resistance.The physician attempted to remove it, but the subject coil was detached prematurely in the catheter.Therefore, the subject coil was removed by cutting off the proximal part of the microcatheter.The procedure was completed successfully by replacing the subject device.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET TETRA 2.0MM X 2.5CM
• 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: 18384481
• Report Number: 3008881809-2023-00597
• Device Sequence Number: 4196863
• Product Code: HCG
• UDI-Device Identifier: 07613327578577
• UDI-Public: 07613327578577
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K222533
• 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): 01/29/2024

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 Catalogue Number: TG5412025
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/07/2023
• Supplement Date Received by Manufacturer: 01/19/2024
• Initial Report FDA Received Date: 12/22/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: SL10 MICROCATHETER (STRYKER).
• Patient Sex: Unknown