MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2.5MM X 4CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035432540
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2020
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.During visual inspection, the main coil noted to be severely stretched.The main coil suture and near the detachment zone were found broken/fractured.Functional testing was not performed as the main coil was returned broken/fractured.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 introducer sheath was properly seated in the microcatheter hub and the device was not advanced or retracted with force.The device was seen to be damaged when it was returned for analysis.The main coil was broken fractured from the delivery wire and the delivery wire was not returned for analysis.Therefore, the initial reported defects coil in catheter friction and main coil stretched can be confirmed based on the analysis.The as reported defects coil in catheter friction and main coil stretched as well as the as analyzed defects main coil broken/fractured during use, main coil suture damage and main coil stretched was assigned procedural factors as this complaint 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 factors during use.
Event or Problem Description
Analysis of the returned device found the main coil broken/fractured.There was no clinical consequence to the patient as a result of this event.

• Brand Name: TARGET HELICAL ULTRA 2.5MM 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: 10902421
• Report Number: 3008881809-2020-00367
• Device Sequence Number: 16477865
• Product Code: HCG
• UDI-Device Identifier: 04546540676047
• UDI-Public: 04546540676047
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 11/25/2020

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: 01/21/2022
• Device Model Number: M0035432540
• Device Catalogue Number: M0035432540
• Device Lot Number: 21154065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/02/2020
• Initial Report FDA Received Date: 11/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR