MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET TETRA 3.0MM X 8.0CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	TG5413080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2024
Type of Reportable Event	Malfunction
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 and microscopic inspection, it was observed that the coil delivery wire was seen to be kinked/bent, and the main coil was found to be stretched.The main coil was found to be kinked/bent and broken/fractured.The main coil suture was found to be damaged.Functional inspection could not be performed due to the damage to subject coil.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.During analysis, the coil delivery wire and main coil was noted to be kinked/bent.The main coil was stretched, and the suture of the main coil was damaged.The main coil was also noted to be broken/fractured.The functional inspection couldn't be performed because of the damage.Based on the review of all available information and analysis of the returned device, an assignable cause of procedural factors will be assigned to the as reported coil in catheter friction as this complaint 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 code coil delivery wire kinked/bent since it is most likely that this damage occurred due to handling of delivery wire during the procedure.An assignable cause of procedural factors will be assigned to the as analyzed codes main coil suture damage, main coil kinked/bent, main coil broken/fractured during use and main coil stretched as this complaint 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.
Event or Problem Description
It was reported that the subject coil encountered resistance while being advancing within the microcatheter.The procedure was completed successfully without any clinical consequences to the patient.The subject coil was returned for analysis and the device investigation revealed that the subject coil was found to be broken/fractured during use.

• Brand Name: TARGET TETRA 3.0MM X 8.0CM
• 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: 20887783
• Report Number: 3008881809-2024-00585
• Device Sequence Number: 7902454
• Product Code: HCG
• UDI-Device Identifier: 07613327578669
• UDI-Public: (01)07613327578669(17)270320(10)24870332
• Combination Product (Y/N): N
• Initial Reporter Country: HU
• 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): 12/09/2024

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: TG5413080
• Device Lot Number: 24870332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/28/2024
• Initial Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER).
• Patient Age: 67 YR
• Patient Sex: Female