MAUDE Adverse Event Report: NEURO PACK; RADIOLOGY DIAGNOSTIC KIT

Catalog Number	DYNJ49357A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/08/2018
Event or Problem Description
Pt was in interventional radiology (ir) for a stroke thrombectomy.During the final pass of the device, when the md pulled the stent retriever out, the team noticed a "blue" item within the basket of the device.This "blue" item was not noticed on any prior uses of the device.The device and other catheters on the table were collected and placed into a biohazard bag.The item appears to be blue lint from the towels in the kit.Medline, us.

• Brand Name: NEURO PACK
• Common Device Name: RADIOLOGY DIAGNOSTIC KIT
• MDR Report Key: 7295987
• Report Number: MW5075521
• Device Sequence Number: 1354959
• Product Code: OIP
• UDI-Device Identifier: 10889942564521
• UDI-Public: (01)10889942564521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/22/2018

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2020
• Device Catalogue Number: DYNJ49357A
• Device Lot Number: 17TB9215
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR