MAUDE Adverse Event Report: INDEFLATOR; SYRINGE, BALLOON INFLATION

Patient Problem Insufficient Information (4580)

Event Date 03/29/2024

Event Type  Injury  

Event Description

On friday (b)(6) 2024 provider was doing a peripheral angiogram.The patient had an rt sfa(right superficial femoral artery) lesion, we 1st went in with the 5.0 x 200 evercross and removed unused then went in with a evercross 3.0 ballooned and then removed.Went back in with the 5.0 x 200 inflated and could not get it to deflate.We opened a new indeflator, and tried to deflate with any empty one, this was not deflating it.We call dr (b)(6) and he came tried to help, he called the rep and was doing what the rep explained to try and do, this was not working, a new provider scrubbed in.We cut the hub of the balloon with no feedback, and then we cut the actual catheter this was all unsuccessful.We then prepped the right thigh and with ultrasound and a 18gauge 9cm needle and punctured the balloon, this was successful.Reference reports: mw5153772, mw5153773.

• Brand Name: INDEFLATOR
• Type of Device: SYRINGE, BALLOON INFLATION
• MDR Report Key: 19096077
• MDR Text Key: 340263151
• Report Number: MW5153774
• Device Sequence Number: 1
• Product Code: MAV
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/10/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EVERCROSS PTA DILATION CATHETER
• Patient Outcome(s): Other
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White