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PTS-X™ 613743Recalls & reported problems

B Braun Interventional Systems, Inc · PTSX304 PTSX BALLOON 30MM X 4CM X 80CM · Class 2

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964512094), received between Mar 17, 2017 and Mar 17, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Rupture” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Material Rupture1

Patient problems

  • No Known Impact Or Consequence To Patient1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMar 17, 2017Material Rupture

    AS PER THE REPORT FROM BIS: "WHILE INFLATING THE BALLOON AT THE MAXIMUM SIZE, THE BALLOON RUPTURED. IT RUPTURED AT THE RATED BURST PRESSURE. ACCOUNT THEN WENT TO A BIGGER SIZED BALLOON. A PTSX404 WAS USED TO COMPLETE THE PROCEDURE. NO HARM TO THE PATIENT. THE CATHETER SHAFT WAS NOT KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY." A LATER FOLLOW-UP STATED: "IN AN EMAIL FROM THE ACCOUNT: THEY WERE USING THE BALLOON FOR VESSEL SIZING. AN INFLATION DEVICE WITH PRESSURE GAUGE WAS NOT USED, THEY USED A 60CC SYRINGE. NO PATIENT INFORMATION WILL BE PROVIDED."

    Patient problems: No Known Impact Or Consequence To Patient

    MAUDE report 6412700 ↗

Other Catheter, intravascular occluding, temporary devices

All Catheter, intravascular occluding, temporary devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.