MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL NANO 1.5MM X 2CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035431520
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/10/2021
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 received.The reported lot number was not confirmed as the packaging was not returned with the device.During visual inspection, the coil delivery wire was found to be broken/fractured.The main coil was found to be kinked/bent.The main coil was found to be stretched.The suture was noted to be intact.Functional testing was not performed due to damaged coil delivery wire.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.Additional information provided by the customer indicated that the device was prepared/set-up as per the directions for use with continuous flush being implemented.The device was returned for analysis and the main coil was found stretched and kinked/bent.The delivery wire of the coil was found to be broken/fractured.The event appears 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.Therefore, an assignable cause of procedural factors will be assigned to the ar code 'main coil difficulty inserting' as reported and as analyzed code 'main coil stretched' and ¿main coil kinked/bent' and to the as analyzed codes 'coil delivery wire broken/fractured during use'.
Event or Problem Description
It was reported that during the procedure, physician faced difficulty in pulling the subject coil out of the microcatheter and it got disintegrated and the delivery wire of the subject coil was kinked.The device was returned for analysis and investigation of the device revealed that the delivery wire of the subject coil was fractured/broken during use.No clinical consequences were reported to the patient due to this event.

• Brand Name: TARGET HELICAL NANO 1.5MM X 2CM
• 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: 12276021
• Report Number: 3008881809-2021-00322
• Device Sequence Number: 20019096
• Product Code: HCG
• UDI-Device Identifier: 04546540698032
• UDI-Public: 04546540698032
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 08/04/2021

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: 08/13/2023
• Device Model Number: M0035431520
• Device Catalogue Number: M0035431520
• Device Lot Number: 22368374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/08/2021
• Initial Report FDA Received Date: 08/04/2021
• 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: EXCELSIOR SL-10 MICROCATHETER (STRYKER)