MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 3MM X 8CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035433080
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/19/2020
Type of Reportable Event	Malfunction
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.Visual inspection of the device revealed that the delivery wire was kinked, likely due to handling of the device during use.Additionally, the main coil was kinked and broken.During functional testing, the device was flushed and advanced in a demonstration sl-10 catheter, the resistance was felt.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.In the case of this complaint, it is most likely that anatomical or procedural factors resulted to friction during advancement/retraction of the coil and causing the coil to be kinked and then break during manipulation.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 factor has been assigned to this investigation.
Event or Problem Description
Analysis of the returned device found that the main coil was broken/fractured during use.There was no clinical consequence to the patient as a result.

• Brand Name: TARGET HELICAL ULTRA 3MM X 8CM
• 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: 10659847
• Report Number: 3008881809-2020-00295
• Device Sequence Number: 3168573
• Product Code: HCG
• UDI-Device Identifier: 04546540676085
• UDI-Public: 04546540676085
• 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): 10/09/2020

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: 06/17/2022
• Device Model Number: M0035433080
• Device Catalogue Number: M0035433080
• Device Lot Number: 21522894
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/19/2020
• Initial Report FDA Received Date: 10/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR