MAUDE Adverse Event Report: COOK INCORPORATED GUNTHER TULIP; FILTER, INTRAVASCULAR, CARDIOVASCULAR

Model Number G13287

Device Problem Split (2537)

Patient Problem No Information (3190)

Event Date 06/26/2017

Event Type  malfunction  

Event Description

When the doctor advanced a sheath over the filter to remove it, the sheath split.Device removed, doctor inspected it and we placed it off the field and in biohazard bag.Device to be returned to manufacturer rep.

• Brand Name: GUNTHER TULIP
• Type of Device: FILTER, INTRAVASCULAR, CARDIOVASCULAR
• Manufacturer (Section D): COOK INCORPORATED; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6684010
• MDR Text Key: 78956935
• Report Number: 6684010
• Device Sequence Number: 1
• Product Code: DTK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/28/2017

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: No Information
• Device Model Number: G13287
• Device Catalogue Number: GTRS-200-RB
• Device Lot Number: 7843710
• 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: 06/28/2017
• Event Location: Other
• Date Report to Manufacturer: 06/28/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/03/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 67 YR