PINNACLE PRECISION ACCESS SYSTEM 70-4160Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00389701010762), received between Feb 1, 2018 and Nov 26, 2019 — classified as 5 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Failure to Advance” (3 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, 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 16, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryNov 26, 2019Break; Break

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5090507. THE EVENT DESCRIPTION STATES: "THAT THE DURING VASCULAR PROCEDURE, THE TIP OF THE WIRE BROKE. THIS WAS SEEN BY FLUOROSCOPY IN THE RIGHT SUPERFICIAL FEMORAL ARTERY (SFA). THEY ATTEMPTED TO SNARE HOWEVER WAS UNABLE TO DO SO. THE COVER STENT DEPLOYED TO STABILIZED PIECE OF WIRE AGAINST WALL OF VESSEL. GUIDEWIRE 0.021"/0.53 MM NITINOL, SHEATH LENGTH - 10 CM, NEEDLE SIZE 21G TAPER."

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 9378470 ↗
• InjuryMay 10, 2019Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED A USER FACILITY MEDWATCH REPORT # (B)(4). THE EVENT DESCRIPTION STATES: "THE PATIENT WAS UNDERGOING A RIGHT SUPERFICIAL FEMORAL ARTERY STENTING AND RIGHT FEMORAL POPLITEAL AND DISTAL VESSEL ARTERIOGRAMS. IT WAS NOTED AT THE END OF THE PROCEDURE THAT THE TERUMO FR. 4 PINNACLE INTRODUCER SHEATH HAD BROKEN OFF. X-RAY REVEALED THE TIP IF THE TERUMO FR.4 INTRODUCER SHEATH REMAINED IN THE SUBCUTANEOUS TISSUE IN THE LEFT GROIN. THE SURGEON DETERMINED THAT IN ORDER TO GET THE SMALL FRAGMENT OUT A CUT DOWN WOULD HAVE TO BE PERFORMED AND THIS WOULD NOT BENEFIT THE PATIENT. THE SURGEON DECIDED TO LEAVE THE TIP IN, AS IT WOULD NOT CAUSE HARM TO THE PATIENT". ADDITIONAL INFORMATION WAS RECEIVED ON MAY 1, 2018. THE PATIENT'S CONDITION WAS REPORTED TO BE STABLE, AND WAS DISCHARGED THE FOLLOWING DAY. A SMALL TIP OF THE INTRODUCER SHEATH HAD BROKEN OFF.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 8599495 ↗
• MalfunctionNov 20, 2018Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT WHEN USING THE IK PRECISION THE DOCTOR GAINED ACCESS IN THE TIBIAL VESSEL WITH THE NEEDLE AND THEN THE .021 NITINOL WIRE WOULD NOT PASS THROUGH THE NEEDLE. A .018 COOK NITINOL STARTER WIRE WAS THEN OPENED AND PASSED THROUGH THE NEEDLE WITH NO ISSUE. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: THE ISSUE OCCURRED WHILE TRYING TO GAIN TIBIAL ACCESS DURING A PAD (PERIPHERAL ARTERY DISEASE) PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8088717 ↗
• MalfunctionNov 20, 2018Failure to Advance; Failure to Advance

  THE USER FACILITY REPORTED THAT WHEN USING THE IK PRECISION THE DOCTOR GAINED ACCESS IN THE TIBIAL VESSEL WITH THE NEEDLE AND THEN THE .021 NITINOL WIRE WOULD NOT PASS THROUGH THE NEEDLE. A .018 COOK NITINOL STARTER WIRE WAS THEN OPENED AND PASSED THROUGH THE NEEDLE WITH NO ISSUE. THE PATIENT WAS STABLE. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2018: THE ISSUE OCCURRED WHILE TRYING TO GAIN TIBIAL ACCESS DURING A PAD (PERIPHERAL ARTERY DISEASE) PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8088716 ↗
• MalfunctionSep 7, 2018Difficult to Flush; Material Puncture/Hole; Difficult to Flush; Material Puncture/Hole

  THE USER FACILITY REPORTED THAT WHILE USING A PRECISION DEVICE THE SHEATH WOULD NOT FLUSH IN THE PATIENT. THE SHEATH WAS REMOVED AND ANOTHER HOLE WAS NOTICED WHERE SALINE WAS SPRAYING OUT. THEY USED ANOTHER PRECISION AND IT WORKED FINE. THE PATIENT WAS REPORTED TO BE FINE. THE PROCEDURE OUTCOME WAS A SUCCESS. ADDITIONAL INFORMATION WAS RECEIVED ON 8/24/2018: THE PROCEDURE WAS A PEDAL CASE. THE SALINE WAS SPRAYING THROUGH A SHEATH. ADDITIONAL INFORMATION WAS RECEIVED ON 8/27/2018: THERE WAS A TINY HOLE ON THE LATERAL PORTION OF THE SHEATH.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7856069 ↗
• InjuryJul 31, 2018Break; Break

  THIS REPORT IS BEING SUBMITTED IN RESPONSE TO AN FDA MEDWATCH REPORT # MW5078309 THAT TERUMO MEDICAL RECEIVED ON JULY 18, 2018. THE EVENT DESCRIPTION STATES THE FOLLOWING: DURING AN ATTEMPT AT FEMORAL ARTERIAL ACCESS, THE NEEDLE WAS INSERTED INTO THE RIGHT FEMORAL ARTERY AND WIRE PLACED THROUGH NEEDLE. THE WIRE WOULD NOT ADVANCE, THEREFORE, THE DOCTOR STARTED TO WITHDRAW IT. AS IT WAS BEING PULLED BACK THROUGH THE NEEDLE, THE WIRE SHEARED OFF AND BECAME LODGED BEHIND THE RIGHT FEMORAL ARTERY (RFA). MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE WIRE WITH A SNARE WITHOUT SUCCESS. THE DOCTOR CONSULTED AND AGREED TO REMOVE THE WIRE. THE WIRE WAS REMOVED FROM AN INCISION IN THE GROIN USING FORCEPS. THE PATIENT REQUIRED THIRTY MINUTES OF PRESSURE BEING HELD AFTER REMOVAL OF THE WIRE TO ACHIEVE HEMOSTASIS AT THE SITE. ADDITIONAL INFORMATION WAS RECEIVED ON 7/23/18: THE TYPE OF PROCEDURE BEING PERFORMED WAS A RIGHT AND LEFT HEART CATH, ANGIOGRAPHY, COIL OCCLUSION OF VENOUS COLLATERAL FROM L INNOMINATE VEIN TO LA USING CONCENTRO HELIX COILS, BALLOON ANGIOPLASTY OF LPA (LEFT PULMONARY ARTERY) STENT, STENT ANGIOPLASTY OF AORTIC RECOARCTATION. THE PATIENT WAS STABLE AND THE PROCEDURE OUTCOME WAS

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7734328 ↗
• InjuryJul 10, 2018Failure to Advance; Device Dislodged or Dislocated

  DURING ATTEMPT AT FEMORAL ARTERIAL ACCESS, ARTERIAL NEEDLE INSERTED INTO R FEMORAL ARTERY AND WIRE PLACED THROUGH NEEDLE. WIRE WOULD NOT ADVANCE; THEREFORE, MD STARTED TO WITHDRAW IT. AS IT WAS BEING PULLED BACK THROUGH NEEDLE, THE WIRE SHEARED OFF AND BECAME LODGED BEHIND RFA. MULTIPLE ATTEMPTS WERE MADE TO RETRIEVE THE WIRE WITH A SNARE WITHOUT SUCCESS. (B)(6) WAS CONSULTED AND AGREED TO REMOVE THE WIRE. THE WIRE WAS REMOVED FROM AN INCISION IN THE GROIN USING FORCEPS. PT REQUIRED 30 MINS OF PRESSURE BEING HELP AFTER REMOVAL OF WIRE TO ACHIEVE HEMOSTASIS AT SITE.

  Patient problems: Foreign Body In Patient

  MAUDE report 7677279 ↗
• InjuryMar 2, 2018Material Frayed; Material Frayed

  PER MEDWATCH (B)(4) RECEIVED BY TERUMO: THE PATIENT PRESENTED WITH AN INTRACRANIAL HEMORRHAGE AND CT FINDINGS SUGGESTIVE OF AN ARTERIOVENOUS MALFORMATION. PATIENT UNDERWENT A DIAGNOSTIC CEREBRAL ANGIOGRAM. DURING REMOVAL OF THE NEEDLE AND WIRE, 1 CM OF FRAYED WIRE WAS RETAINED IN THE SUBCUTANEOUS TISSUE. THE PATIENT HAD A HISTORY OF HYPOPLASTIC LEFT HEART SYNDROME PRESENTING WITH AN INTRACRANIAL HEMORRHAGE.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 7309738 ↗
• MalfunctionFeb 1, 2018Material Frayed

  PATIENT PRESENTED WITH AN INTRACRANIAL HEMORRHAGE AND CT FINDINGS SUGGESTIVE OF AN ARTERIOVENOUS MALFORMATION UNDERWENT A DIAGNOSTIC CEREBRAL ANGIOGRAM. DURING REMOVAL OF THE NEEDLE AND WIRE, 1CM OF FRAYED WIRE WAS RETAINED IN THE SUBCUTANEOUS TISSUE.

  Patient problems: Foreign Body In Patient; Intracranial Hemorrhage

  MAUDE report 7233519 ↗