MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET HELICAL ULTRA 2 MM X 3 CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035432030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/31/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record review confirms that the device met all material, assembly and performance specifications.Analysis of the device revealed that the delivery wire was kinked/bent likely due to handling.Firm coil of the delivery wire was damaged and the delivery wire was broken/fractured at firm coil- wire junction.In addition the main coil was found kinked.Functional test could be not performed on the returned device.In the case of this complaint, it was reported that friction was encountered between the target coil and an sl 10 microcatheter during the procedure.The returned coil was found kinked and the delivery wire was damaged and broken.These defects are consistent with an excessive force being used during withdrawal of the device from the catheter, after unsuccessful advancement.The reported friction was most likely due to some procedural factors encountered during use, leading to the analysed defects.Based on the investigation results and available information an assignable cause of procedural factors will be assigned to the analyzed damages and the break.
Event or Problem Description
Analysis of the device revealed that the coil delivery wire was broke.No clinical consequences were reported to the patient.

• Brand Name: TARGET HELICAL ULTRA 2 MM X 3 CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 8242491
• Report Number: 3008881809-2019-00023
• Device Sequence Number: 13991912
• Product Code: HCG
• UDI-Device Identifier: 04546540675996
• UDI-Public: 04546540675996
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 01/11/2019

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: 04/04/2021
• Device Catalogue Number: M0035432030
• Device Lot Number: 20451852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 01/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1