ARROW IPN920375Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10801902194173), received between May 9, 2023 and May 9, 2023 — classified as 1 injury.

The most frequently reported specific device problem is “Material Separation” (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.

• InjuryMay 9, 2023Material Separation; Material Separation

  MEDWATCH RECEIVED REPORTS: "ON [REDACTED DATE], THE PATIENT UNDERWENT CORONARY BRACHYTHERAPY VIA RIGHT FEMORAL ARTERIAL ACCESS. LATER THAT SAME DAY WHILE THE PROVIDER WAS ATTEMPTING TO GENTLY REMOVE THE FEMORAL ACCESS CATHETER WITH MINIMAL TRACTION, THE HEAD OF THE CATHETER AND SIDE PORT FRACTURED OFF WITH THE CATHETER SHAFT STILL REMAINING IN SITU AND A RUSH OF BRISK ARTERIAL BLOOD FOLLOWED. THE PROVIDER IMMEDIATELY APPLIED AND MAINTAINED MANUAL PRESSURE PROXIMALLY TO THE ARTERIOTOMY SITE AGAINST THE FEMORAL HEAD, WITH HE MOSTASIS WAS ACHIEVED. VASCULAR SURGERY WAS STAT PAGED TO THE PATIENT'S BEDSIDE AS PROVIDER CONTINUED TO HOLD MANUAL PRESSURE THROUGHOUT THE ENTIRE TIME. THE PATIENT WAS THEN TAKEN EMERGENTLY TO THE OR FOR EXPLORATION AND REMOVAL OF RETAINED ACCESS CATHETER. THE SPECIFIC INTRODUCER USED WAS A "SET INTRODUCER SUPER ARROW-FLEX 7FR 11CM HEMOSTATIC VALVE PERCUTANEOUS SHEATH INTEGRAL SIDE PORT ATTACHED 3WAY STOPCOCK RADIOPAQUE TIP ORANGE CS/10EA".

  Patient problems: Foreign Body In Patient; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16898797 ↗