PTS® 613704Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04046964310997), received between Jun 1, 2017 and Jun 1, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Kinked” (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

Recent adverse event reports

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

• MalfunctionJun 1, 2017Kinked; Material Rupture

  AS PER HOSPITAL MEDWATCH REPORT: "A MALE PATIENT WITH HISTORY OF BICUSPID AORTIC VALVE DISEASE STATUS POST ROSS PROCEDURE WITH RESULTING STENOTIC PULMONARY HOMOGRAFT ADMITTED FOR TRANSCATHETER PULMONARY VALVE REPLACEMENT. BALLOON SIZING OF THE PULMONARY ARTERY WITH DYNA CT PERFORMED WITH A 30 MM X 5 CM NUMED PERCUTANEOUS TRANSLUMINAL SIZING (PTS) SIZING BALLOON. BALLOON WAS ADVANCED INTO THE RIGHT VENTRICULAR OUTFLOW TRACT (RVOT) AND MAIN PULMONARY ARTERY AND INFLATED UNDER RAPID PACING. THE BALLOON RUPTURED AT LOW PRESSURE REQUIRING REMOVAL OF 16F SHEATH AND REPLACEMENT WITH A 16F SHORT COOK SHEATH AND THE BALLOON WAS SUCCESSFULLY RETRIEVED. THE PROCEDURE WAS ABORTED AND RESCHEDULED." ADDITION INFORMATION PER DISTRIBUTOR: "IT IS UNKNOWN WHETHER AN INFLATION DEVICE WITH PRESSURE GAUGE WAS USED. THE CATHETER SHAFT WAS KINKED. THERE WAS NOTHING UNUSUAL ABOUT THE PATIENT ANATOMY. THE PATIENT WAS STABLE POST PROCEDURE. THE BALLOON RUPTURED CIRCUMFERENTIALLY, IT IS UNKNOWN AT WHAT ATM THE BALLOON RUPTURED - THE REPORT STATES ONLY 'AT LOW PRESSURE'."

  Patient problems: No Code Available

  MAUDE report 6604958 ↗