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

Model Number M0035442040

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/26/2018

Event Type  malfunction  

Event Description

The target coil would not exit the housing shell it is packaged in.

• Brand Name: TARGET
• Type of Device: DEVICE, NEUROVASCULAR EMBOLIZATION
• Manufacturer (Section D): STRYKER CORPORATION; 47900 bayside parkway; fremont CA 94538
• MDR Report Key: 8266974
• MDR Text Key: 133762083
• Report Number: 8266974
• Device Sequence Number: 1
• Product Code: HCG
• UDI-Device Identifier: 07613252600299
• UDI-Public: (01)07613252600299(17)210131(10)20284901
• 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: 01/15/2019

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
• Device Operator: Health Professional
• Device Model Number: M0035442040
• Device Catalogue Number: 544204
• Device Lot Number: 20284901
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/15/2019
• Event Location: Hospital
• Date Report to Manufacturer: 01/22/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/22/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 21900 DA
• Patient Weight: 47