PristineRecalls & reported problems across all models

We found 3 models of Pristine by Bard Peripheral Vascular, Inc. in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Jan 3, 2022 and Sep 4, 2023 — classified as 4 injuries, 16 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Pristine problems

Pristine models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Pristine 5403230

  Catheter, hemodialysis, implanted
  11 reports
• Pristine 5403190

  Catheter, hemodialysis, implanted
  5 reports
• Pristine 5403280

  Catheter, hemodialysis, implanted
  4 reports

Recent Pristine adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2023Loss of or Failure to Bond; Dent in Material; Free or Unrestricted Flow; Loss of or Failure to Bond; Dent in Material; Free or Unrestricted Flow

  IT WAS REPORTED THAT SOMETIME POST A DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY HAD INDENTATION IN VENOUS/BLUE LUMEN UNDER FIBRO GENIC CUFF. IT WAS FURTHER REPORTED THAT THE CATHETER ALLEGEDLY HAD HIGH PRESSURES PROBLEMS, DIFFICULTY WITH ASPIRATION AND FLOW ISSUES. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17675389 ↗
• MalfunctionJun 1, 2023Restricted Flow rate; Deformation Due to Compressive Stress; Restricted Flow rate; Deformation Due to Compressive Stress

  IT WAS REPORTED THAT SOME TIME POST A DIALYSIS CATHETER PLACEMENT, THE TUBING NEAR THE HUB ALLEGEDLY KINKED. IT WAS FURTHER REPORTED THAT DEVICE ALLEGEDLY HAD POOR FLOW. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17036860 ↗
• MalfunctionMay 9, 2023Fracture; Material Separation; Difficult or Delayed Separation; Fracture; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE SHEATH ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE DEVICE PEELED AWAY, AND THE HANDLE OF THE SHEATH BROKE OFF. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16892923 ↗
• MalfunctionApr 27, 2023Difficult to Flush; Suction Problem; Obstruction of Flow; Difficult to Flush; Suction Problem; Obstruction of Flow

  IT WAS REPORTED THAT SIX DAYS POST DIALYSIS CATHETER PLACEMENT, THE CATHETER ALLEGEDLY CLOTTED. IT WAS FURTHER REPORTED THAT THE CATHETER DID NOT WORK. REPORTEDLY, THE CATHETER WAS REMOVED AND REPLACED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16826704 ↗
• MalfunctionApr 17, 2023Fracture; Material Separation; Difficult or Delayed Separation; Fracture; Material Separation; Difficult or Delayed Separation

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE DEVICE SHEATH ALLEGEDLY CRACKED. IT WAS FURTHER REPORTED THAT THE DEVICE PEELED AWAY AND THE HANDLE OF THE SHEATH BROKE OFF. REPORTEDLY, THE DEVICE WAS REMOVED. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16750843 ↗
• InjuryApr 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SOMETIME POST CHRONIC CATHETER PLACEMENT, CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION WAS ALLEGEDLY DEVELOPED IN THE PATIENT¿S CENTRAL LINE. IT WAS FURTHER REPORTED THAT CULTURE WAS TAKEN FROM THE LINE AND LABORATORY INFECTION CONFIRMED THE GROWTH OF SPHINGOMONAS PAUCIMOBILIS BACTERIA. FURTHERMORE, PATIENT ALLEGEDLY HAD URINARY TRACT INFECTION AND EXPERIENCED SYMPTOMS OF TACHYCARDIA, HYPOTENSION, LETHARGY, AND FEVER. REPORTEDLY, ANTIBIOTICS WERE ADMINISTERED TO TREAT CENTRAL LINE-ASSOCIATED BLOODSTREAM INFECTION. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Bacteremia; Bacterial Infection; Urinary Tract Infection

  MAUDE report 16704341 ↗
• MalfunctionDec 2, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT PRIOR TO DIALYSIS CATHETER PLACEMENT PROCEDURE, FOREIGN MATERIAL WAS ALLEGEDLY FOUND ON THE PACKAGE. THERE WAS NO PATIENT CONTACT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15903191 ↗
• MalfunctionSep 14, 2022Air/Gas in Device; Air/Gas in Device

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, AIR ALLEGEDLY LEAKED AROUND THE HUB ON THE ARTERIAL LUMEN SIDE. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15415994 ↗
• InjuryAug 10, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED IN A CLINICAL STUDY THAT APPROXIMATELY, ONE MONTH AND TWENTY-FIVE DAYS POST AN ULTRASOUND GUIDED RIGHT INTERNAL JUGULAR VEIN APPROACH HEMODIALYSIS CATHETER PLACEMENT PROCEDURE, PATIENT HAD AN ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15196954 ↗
• MalfunctionJul 20, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT SOMETIME POST DIALYSIS CATHETER PLACEMENT, DEVICE ALLEGEDLY HAD OBSTRUCTION OF FLOW. THE PROCEDURE WAS COMPLETED USING ANOTHER DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15062799 ↗
• InjuryJul 12, 2022Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THROUGH A CLINICAL TRIAL, THAT APPROXIMATELY TWENTY DAYS POST DIALYSIS PLACEMENT PROCEDURE IN THE RIGHT INTERNAL JUGULAR VEIN APPROACH, PATIENT HAD AN ADVERSE EVENT OF CLOTTED CATHETER. IT WAS FURTHER REPORTED THAT CATHETER WAS REMOVED AND EXCHANGED. THE CURRENT STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 14984025 ↗
• MalfunctionJun 6, 2022Difficult to Insert; Difficult or Delayed Separation; Difficult to Insert; Difficult or Delayed Separation

  IT WAS REPORTED THAT SOMETIME POST PORT PLACEMENT, THE PEEL AWAY SHEATH FELL APART AND ALLEGEDLY START CRACKING ONE DILATOR WAS REMOVED. IT WAS FURTHER REPORTED THAT THE FINISHING INSERTION WAS ALLEGEDLY VERY DIFFICULT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14600567 ↗
• MalfunctionJun 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE CATHETER WAS ALLEGEDLY DETACHED FROM THE TUNNELER DURING PLACEMENT. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14571521 ↗
• MalfunctionMar 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A DIALYSIS CATHETER PLACEMENT PROCEDURE, THE PHYSICIAN ATTEMPTED TO PULL THE CATHETER MULTIPLE TIMES BUT KEPT DISCONNECTING MULTIPLE TIMES UNDER THE SKIN FROM TUNNELLER. THE PROCEDURE WAS COMPLETED USING THE SAME DEVICE. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13826666 ↗
• MalfunctionMar 17, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A CATHETER PLACEMENT PROCEDURE, THE DEVICE TUNNELER ALLEGEDLY FELL OFF. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13791902 ↗

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