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 Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/15/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes system there are controls in the manufacturing process to ensure the product met specifications upon release.The device was returned, and reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the coil delivery wire was noted to be kinked.The main coil was seen to be detached and kinked/bent.Functional testing could not be carried out as the coil was detached.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 complaint was confirmed based on analysis.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.On visual inspection the coil delivery wire was found to be kinked.The main coil was seen to be kinked and detached from the delivery wire.Based on a review of the available information and analysis of the returned device, it is probable that there may have been procedural/anatomical factors present, which led to the premature detachment of the coil.An assignable cause of procedural factors will be assigned to the as reported event of main coil failed/unable to detach as this defect 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 procedural factors will be assigned to the as analyzed events of main coil kinked/bent and main coil prematurely detached/separated during use as this defect 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 event of 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
The coil (subject device) was returned for analysis and the device investigation revealed that the coil (subject device) detached prematurely during use.The procedure was completed successfully with another 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: 18799430
• Report Number: 3008881809-2024-00077
• Device Sequence Number: 7131099
• Product Code: HCG
• UDI-Device Identifier: 07613327578577
• UDI-Public: 07613327578577
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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
• Report Date (Section B): 02/28/2024

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 Expiration Date: 02/28/2026
• Device Catalogue Number: TG5412025
• Device Lot Number: 24207685
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/26/2024
• Initial Report FDA Received Date: 02/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2023
• 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: INZONE POWER SUPPLY (STRYKER); SL-10 MICROCATHETER (STRYKER)
• Patient Age: 60 YR
• Patient Sex: Female