MAUDE Adverse Event Report: STRYKER NEUROVASCULAR TARGET; DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION

Model Number	M0035422540
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
The coil would not pass through the introducer sheath.The coil did not touch the patient.

• Brand Name: TARGET
• Common Device Name: DEVICE, VASCULAR, FOR PROMOTING EMBOLIZATION
• Manufacturer (Section D): STRYKER NEUROVASCULAR; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 7983443
• Report Number: 7983443
• Device Sequence Number: 165276
• Product Code: KRD
• UDI-Device Identifier: 04546540675866
• UDI-Public: (01)04546540675866(17)210612(10)20610863
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 10/18/2018
• Report Date (Section F): 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M0035422540
• Device Catalogue Number: 542254
• Device Lot Number: 20610863
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2018
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 53
• Date Report Sent to FDA: 10/18/2018