MAUDE Adverse Event Report: ANGIOADVANCEMENTS, LLC ANGIASSIST; TUBING, PRESSURE AND ACCESSORIES

Catalog Number AA0608

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/12/2017

Event Type  malfunction  

Event Description

During procedure using co2, it was noted that one of the syringes broke off in the 3-way stopcock, allowing air to get in.It was corrected right away before it was used on the pt.A new co2 set-up was obtained and used.This was an equipment issue.The tip of the syringe actually broke off into the stop cock.Once this was discovered, it was replaced with a new one and the case continued with no further problems.No injury to patient.Device was not sequestered and is not available for return.

• Brand Name: ANGIASSIST
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): ANGIOADVANCEMENTS, LLC; shelby lane; north ft myers FL 33917
• MDR Report Key: 7479405
• MDR Text Key: 107098796
• Report Number: 7479405
• Device Sequence Number: 1
• Product Code: BYX
• 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: 04/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Unknown
• Device Catalogue Number: AA0608
• Device Lot Number: 7108
• 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: 04/26/2018
• Event Location: Hospital
• Date Report to Manufacturer: 04/26/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 52 YR