MAUDE Adverse Event Report: UNKNOWN TOWEL CLIP; ACCESSORY, SURGICAL APPAREL

Device Problem Material Puncture/Hole (1504)

Patient Problem No Information (3190)

Event Date 04/18/2016

Event Type  malfunction  

Event Description

After the drapes were removed and the transcatheter aortic valve replacement (tavr) case was completed, a small puncture to the left foot was noted from the towel clip.A band-aid was applied and the physician made aware.This is a metal re-usable towel clip found in the surgeon's tray.Staff training was completed with the cardiovascular operating room (cvor) team as process improvement education for awareness of patient healthy tissue when using towel clips to hold up drapes and towels.No identifying information is available regarding device.

• Brand Name: TOWEL CLIP
• Type of Device: ACCESSORY, SURGICAL APPAREL
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 5839543
• MDR Text Key: 50930129
• Report Number: 5839543
• Device Sequence Number: 1
• Product Code: LYU
• 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: Other
• Type of Report: Initial
• Report Date: 06/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/03/2016
• Event Location: Hospital
• Date Report to Manufacturer: 06/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 86 YR