Prytime Medical Devices, Inc. KT1835CRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00863092000101), received between Feb 8, 2024 and Sep 13, 2024 — classified as 5 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF A THROMBUS REQUIRING A THROMBECTOMY FOR TREATMENT. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. ON (B)(6) 2024 PRYTIME WAS INFORMED OF THE FOLLOWING CASE. A FEMALE PATIENT INVOLVED IN A MOTOR VEHICLE COLLISION ARRIVED AT THE FACILITY HYPOTENSIVE. CT IMAGING IDENTIFIED BLEEDING FROM THE LIVER AND COLON. THE PATIENT WAS TAKEN TO THE OR, WHERE AN EX-LAP WAS PERFORMED. A 7 FR INTRODUCER SHEATH WAS PLACED IN THE COMMON FEMORAL ARTERY (CFA). A REBOA CATHETER WAS PLACED THROUGH THE INTRODUCER SHEATH AND INFLATED. THE LIVER AND COLON WERE REPAIRED BUT THERE CONTINUED TO BE HIGH LEVELS OF ARTERIAL BLEEDING WITHOUT A GOOD SOURCE. THE PORTAL VEIN BRANCHES WERE LIGATED. AFTER THE BLEEDING WAS STABLE, THE REBOA CATHETER WAS DEFLATED AND REMOVED. THE INTRODUCER SHEATH REMAINED IN PLACE IN THE PATIENT. AT THIS POINT, THE PATIENT HAD A GOOD BLOOD PRESSURE (BP) DISTAL TO THE INTRODUCER SHEATH. THE PATIENT STARTED BLEEDING AGAIN IN THE ICU. DUE TO THE ONGOING HEMODYNAMIC INSTABILITY, A SECON

  Patient problems: Thrombosis/Thrombus

  MAUDE report 20211833 ↗
• InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO THE DISSECTION OF A PATIENT'S RIGHT ILIAC ARTERY, REQUIRING SURGICAL INTERVENTION FOR REPAIR. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THE CASE INVOLVED A 17-YEAR-OLD MALE PATIENT WHO WAS PRESENTED TO THE FACILITY AFTER SUSTAINING A GUNSHOT WOUND AT CLOSE RANGE WITH AN ASSAULT RIFLE. THE PATIENT'S INJURIES WERE IDENTIFIED AT THE LEFT BUTTOCKS AND HIP, POSSIBILITY AN EXIT WOUND IN THE LEFT GROIN. UPON ARRIVAL, THE PATIENT WAS IN HEMORRHAGIC SHOCK, TACHYCARDIC WITH A LOW BLOOD PRESSURE IN THE 60'S. BLOOD PRODUCTS WERE ADMINISTERED IN THE ED AND THEN THE PATIENT WAS TRANSFERRED TO THE OR. IN THE OR, PERCUTANEOUS ACCESS WAS GAINED AT THE RIGHT COMMON FEMORAL ARTERY (CFA) VIA A 7FR SHEATH. INITIAL PLACEMENT OF THE REBOA CATHETER WAS INSERTED AND INFLATED AT ZONE-1 FOR APPROXIMATELY 10 MINUTES AND THEN ADJUSTED TO ZONE-3 FOR 20 MINUTES; TOTAL OCCLUSION TIME WAS APPROXIMATELY 30 MINUTES. PER THE MEDICAL TEAM AT THE USER FACILITY, IT WAS UNKNOWN IF PARTIAL OR COMPLETE OCCLUSION WAS UTILIZED. NO I

  Patient problems: Vascular Dissection

  MAUDE report 19510503 ↗
• InjuryJun 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF A THROMBUS FORMATION REQUIRING A THROMBECTOMY FOR TREATMENT. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THE CASE INVOLVED A MALE PATIENT WHO WAS PRESENTED TO THE FACILITY AFTER SUSTAINING A FALL INJURY A DAY OR TWO PRIOR. THE PATIENT WAS INITIALLY PRESENTED TO ANOTHER FACILITY AND THEN TRANSFERRED TO THE CURRENT REPORTING FACILITY. THE PATIENT WAS HYPOTENSIVE UPON ARRIVAL WITH AN SBP IN THE 80'S AND INTO THE 70'S WITH TWO VASOPRESSORS INFUSING. PERCUTANEOUS ACCESS WAS GAINED AT THE LEFT COMMON FEMORAL ARTERY (CFA). THE MEDICAL TEAM EXPRESSED SOME DIFFICULTIES GAINING ACCESS AND INSERTION DUE TO THE PATIENT'S LARGE SIZE BUT WAS ULTIMATELY SUCCESSFUL. IT WAS LATER NOTED THAT THE PATIENT'S CFA WAS A VERY SMALL CALIBER AND WAS CONFIRMED TO HAVE ARTERIAL CALCIFICATION AND ARTERIOSCLEROSIS. THE REBOA CATHETER WAS PLACED IN ZONE-1 AND THE BALLOON WAS INFLATED FOR APPROXIMATELY 1.58 HOURS AT PARTIAL OCCLUSION. THERE WERE NO ISSUES ENCOUNTERED WITH THE USE OF THE CATHETER OR THE S

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19470359 ↗
• InjuryApr 30, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF A THROMBUS. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THE CASE INVOLVED A 34-YEAR-OLD FEMALE PATIENT WHO WAS PRESENTED TO THE FACILITY WITH HEAVY VAGINAL BLEEDING AND DEMONSTRATED TACHYCARDIA AND HYPOTENSION. THE PATIENT WAS FOUND TO HAVE PREVIA AND PLACENTA ACCRETA SPECTRUM. ESTIMATED BLOOD LOSS WAS 1 LITER AND MTP WAS STARTED. CESAREAN SECTION WAS PERFORMED WITHOUT INCIDENT. AN ADDITIONAL 2 LITERS OF BLOOD LOSS WAS NOTED WITH ONGOING BLOOD LOSS FROM ALL SURFACES. THE UTERUS DEMONSTRATED DENSE ADHERENCE TO THE PELVIC SIDEWALLS, THE BLADDER, AND URETERS. ONCE REBOA PROCEDURE WAS DETERMINED, PERCUTANEOUS ACCESS WAS GAINED AT THE RIGHT COMMON FEMORAL ARTERY (CFA); MICRO-PUNCTURE WAS EXCHANGED FOR 7FR SHEATH. DUE TO THE PATIENT'S SMALL HABITUS, THERE WAS DIFFICULTY DURING ACCESS, BUT EVENTUALLY ACCESS WAS GAINED. IT WAS NOTED THAT THE PATIENT WAS SMALL, AND THE CFA WAS LESS THAN 4MM. THE REBOA CATHETER WAS PLACED AND PERIODICALLY CYCLED (INFLATE AND DEFLATE) FOR APPROXIMATE

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19218005 ↗
• InjuryFeb 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PRYTIME IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF A PSEUDOANEURYSM. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THIS CASE INVOLVED AN 83-YEAR-OLD PATIENT WHO WAS PRESENTED TO THE FACILITY AFTER BEING INVOLVED IN A HEAD ON MOTOR VEHICLE CRASH. THE PATIENT SUSTAINED FRACTURES IN ALL FOUR EXTREMITIES AND WAS A TRANSIENT RESPONDER TO ONE UNIT OF BLOOD. IN ADDITION, THE PATIENT WAS A BREAST CANCER SURVIVOR WITH BAD LYMPHEDEMA. PERCUTANEOUS ACCESS WAS GAINED AT THE LEFT COMMON FEMORAL ARTERY (CFA) AND THE REBOA BALLOON CATHETER WAS PLACED. THERE WERE NO ISSUES ENCOUNTERED WITH THE USE OF THE CATHETER AND SHEATH DURING THE REBOA PROCEDURE. A CT REVEALED THE PATIENT HAD A SEVERE SPLENIC LACERATION REQUIRING THE REMOVAL OF THE SPLEEN. ONCE THE SURGICAL PROCEDURE WAS COMPLETED, THE CATHETER WAS REMOVED WITHOUT ISSUE AND THE SHEATH REMAINED. THE PATIENT WAS TRANSFERRED TO ICU AND PLACED ON A LOW DOSE OF LEVOPHED AND VASOPRESSIN WITH STABLE HEMOGLOBIN. THE PATIENT'S LACTATE REMAINED ELEVATED. THE FOLLOWING DAY, A PSEUDOANEURYSM WAS NOT

  Patient problems: Pseudoaneurysm

  MAUDE report 18673152 ↗