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

Model Number	M0035442040
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Due to the automated mes (manufacturing execution system) 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, the coil delivery wire was seen to be broken, the main coil was seen to be kinked/bent, and the main coil was seen to be stretched.Functional test was unable to carry out due to the damage on the main coil.The reported defect was not confirmed however, the analysis results are consistent with the event.The device failed to meet specifications when received for complaint investigation based on the analyzed anomalies noted to the device.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 ar codes 'main coil difficulty inserting' and 'coil in catheter friction' were not confirmed during analysis.Therefore, an assignable cause of 'not confirmed' will be assigned to the ar codes 'main coil difficulty inserting' and 'coil in catheter friction'.The main coil was found to be stretched and kinked/bent.The coil delivery wire was found to be kinked/bent and broken.An assignable cause of 'handling damage' will be assigned to the aa codes 'coil delivery wire kinked/bent' as the defect appears to be associated with handling of the product or portion of the product during the procedure/upon removal of the product from the packaging/preparation of the product prior to use and an assignable cause of procedural factors will be assigned to aa codes 'coil delivery wire broken/fractured during use', 'main coil kinked/bent' and 'main coil stretched' as this defects appear to be associated with a product that met stryker and design and manufacturing specifications and was used in accordance with the dfu, but performance was limited due to procedural or anatomical factors during use.
Event or Problem Description
Analysis of the returned device found the coil delivery wire broken/fractured during use.There were no clinical consequences to the patient reported as a result of this event.

• Brand Name: TARGET 360 NANO 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
• MDR Report Key: 12669764
• Report Number: 3008881809-2021-00444
• Device Sequence Number: 4298520
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: 07613252600299
• Combination Product (Y/N): N
• Initial Reporter Country: EG
• PMA/510(K) Number: K153658
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/20/2021

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: 01/10/2024
• Device Model Number: M0035442040
• Device Catalogue Number: M0035442040
• Device Lot Number: 22678094
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/30/2021
• Initial Report FDA Received Date: 10/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 6F GUIDE CATHETER (CHAPERON MANUFACTURER); SL-1O MICROCATHETER (STRYKER MANUFACTURER)