MAUDE Adverse Event Report: STRYKER NEUROVASCULAR CORK TARGET 360 SOFT 5MM X 15CM; DEVICE, NEUROVASCULAR EMBOLIZATION

Catalog Number	M0035475150
Medical Device Problem Codes	Fracture (1260); Premature Separation (4045)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record confirms that the device met all material, assembly and performance specifications.Visual inspection was performed on the returned sample and it was observed the proximal contact wire was intact.The coil delivery wire was kinked, and stretched.The main coil was detached, and the delivery wire was broken.The distal tip was found to be intact.The suture was damaged.Functional testing could not be carried out as the coil was detached and coil delivery wire was broken.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 reported event was confirmed.It is probable that the device was damaged during the clinical procedure due to some procedural/anatomical factors encountered causing the as reported event, therefore therefore assignable cause of procedural factors will be assigned to reported and analyzed issues.
Event or Problem Description
Analysis of the returned device found the delivery wire broken and the coil detached.The coil was replaced and the procedure was completed successfully.There were no clinical consequences to the patient.

• Brand Name: TARGET 360 SOFT 5MM X 15CM
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR CORK; ida industrial estate; model farm road; cork NA
• MDR Report Key: 9520596
• Report Number: 3008881809-2019-00408
• Device Sequence Number: 3244428
• Product Code: HCG
• UDI-Device Identifier: 04546540676504
• UDI-Public: 04546540676504
• Combination Product (Y/N): N
• 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): 12/26/2019

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: 07/20/2022
• Device Catalogue Number: M0035475150
• Device Lot Number: 21607754
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/03/2019
• Initial Report FDA Received Date: 12/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1