MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 ULTRA 2MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035422040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The coil (subject device) was returned for analysis and the device investigation revealed that the coil (subject device) was fractured during use.The physician replaced it with a new device and continued the procedure without clinical consequences to the patient.
Additional Manufacturer Narrative
Due to the automated manufacturing execution system (mes) system there are controls in the manufacturing process to ensure the product met specifications upon release.During visual inspection, the coil delivery wire was seen to be kinked/bent in multiple areas.The main coil was seen to be stretched.The main coil suture was seen to be damaged.The main coil was seen to be broken/fractured.Functional and dimensional testing could not be carried out due to the condition of the device.The reported coil in catheter friction could not be replicated during device analysis; however, the analysis results are consistent with the reported event.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 device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.Additional information provided by the customer indicated the device was prepared for use as per the dfu.Continuous flush was set up and maintained throughout the procedure.There was friction noted within the microcatheter.The device was retracted and a new one was used to finish the procedure.The patients anatomy was moderately tortuous.The device was analyzed and the coil delivery wire was kinked in numerous areas.The main coil was seen to be fractured, stretched and the suture was damaged.Functional and dimensional testing could not be carried out due to the condition of the device.An assignable cause of procedural factors will be assigned to the as reported event of coil in catheter friction 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 event of coil delivery wire kinked/bent as the defect appears to be associated with handling of the product or portion of the product during removal from the hoop and preparation.An assignable cause of procedural factors will be assigned to the as analyzed events of main coil broken/fractured during use, main coil stretched and main coil suture damaged 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.

• Brand Name: TARGET 360 ULTRA 2MM X 4CM
• 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: 19506024
• Report Number: 3008881809-2024-00261
• Device Sequence Number: 15327973
• Product Code: HCG
• UDI-Device Identifier: 04546540675842
• UDI-Public: 04546540675842
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K153658
• 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): 06/10/2024

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: 06/19/2026
• Device Catalogue Number: M0035422040
• Device Lot Number: 24385455
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/27/2024
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/21/2023
• 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: XT-17 MICROCATHETER (STRYKER)
• Patient Sex: Male
• Patient Race: Asian