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

Model Number M0035443560

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2020

Event Type  malfunction  

Event Description

The target coil didn't deploy out of the casing; it did not push out of the sheath.It did not come in contact with the patient.Manufacturer response for device, neurovascular embolization, target (per site reporter).They sent a (b)(6) label to return the device to the manufacturer.

• Brand Name: TARGET
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 5900 optical ct; san jose CA 95138
• MDR Report Key: 10894160
• MDR Text Key: 217948551
• Report Number: 10894160
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600343
• UDI-Public: (01)07613252600343(17)230715(10)22330936
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M0035443560
• Device Catalogue Number: 544356
• Device Lot Number: 22330936
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/18/2020
• Event Location: Hospital
• Date Report to Manufacturer: 11/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 25550 DA
• Patient Weight: 79