MAUDE Adverse Event Report: STRYKER CORPORATION TARGET; DEVICE, NEUROVASCULAR EMBOLIZATION

Model Number	M0035421540
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
One coil failed during deployment and broke off in catheter, which resulted in the other coils not being able to deploy, and the detacher stopped working during the case.

• Brand Name: TARGET
• Common Device Name: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 15437488
• Report Number: 15437488
• Device Sequence Number: 14945667
• Product Code: HCG
• UDI-Device Identifier: 04546540697998
• UDI-Public: (01)04546540697998
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 08/26/2022
• Report Date (Section F): 09/13/2022

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 Model Number: M0035421540
• Device Catalogue Number: 542154
• Device Lot Number: 23576672
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/16/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 90 KG
• Date Report Sent to FDA: 09/13/2022