MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 10CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the procedure, the subject coil was damaged at the detachment zone and it was observed the detachment zone snapped on the wire of the subject coil.The subject coil was removed without any issue.No further information is available.
Event or Problem Description
It was reported that during the procedure, the subject coil was damaged at the detachment zone and it was observed the detachment zone snapped on the wire of the subject coil.The subject coil was removed without any issue.No further information is available.
Additional Manufacturer Narrative
D4 expiration date - added.H4 manufacturing date ¿ added.Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.The subject device is not available; therefore, visual and functional testing as well as physical analysis cannot be performed.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 could not be confirmed, and it could not be definitively determined if the device failed to meet specifications because the product was not returned.While there are a number of potential causes for the reported issue, because review and analysis of available information failed to identify a definitive cause, an assignable cause of undeterminable was assigned to the as reported event of the coil delivery wire broken/fractured during use.

• Brand Name: TARGET TETRA 3.0MM X 10CM
• 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: 19923969
• Report Number: 3008881809-2024-00355
• Device Sequence Number: 8094830
• Product Code: HCG
• UDI-Device Identifier: 07613327578676
• UDI-Public: 07613327578676
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,Followup
• Report Date (Section B): 09/03/2024

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: 09/18/2026
• Device Catalogue Number: TG5413010
• Device Lot Number: 24540153
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 08/14/2024
• Initial Report FDA Received Date: 08/06/2024
• Supplement Report FDA Received Date: 09/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Female