PINNACLE PRECISION ACCESS SYSTEM 70-7160Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00389701010793), received between Aug 28, 2017 and Apr 14, 2023 — classified as 3 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryApr 14, 2023Break; Break

  THE USER FACILITY REPORTED THAT THE IK PRECISION DEVICE, WIRE WOULD NOT PASS THROUGH THE SHEATH. THE WIRE HAD TO BE RETRIEVED FROM THE ARTERY. THE PATIENT WAS IN STABLE CONDITION. THE EVENT OCCURRED INTRA-OPERATIVE. MEDICAL/SURGICAL INTERVENTION WAS REQUIRED. THE PROCEDURE OUTCOME WAS SUCCESSFUL. ADDITIONAL INFORMATION 20P MAR 2023: PROCEDURE PERFORMED WAS A LEFT AND RIGHT HEART CATH. WHEN THEY WERE GAINING ACCESS, THE DOCTOR ATTEMPTED TO FEED THE WIRE THROUGH THE NEEDLE AND THE TIP OF THE WIRE WAS KNOTTED UP, WITHIN THE NEEDLE. THE DOCTOR ATTEMPTED TO REMOVE THE WIRE; HOWEVER, IT WAS STUCK IN THE NEEDLE. A 10 FRENCH CATHETER WAS THREADED OVER THE WIRE TO TRY AND REMOVE THE TRAPPED WIRE BACK THROUGH HOWEVER THAT DID NOT WORK EITHER. WHEN THE DOCTOR PULLED THE WIRE BACK, THE TIP OF THE WIRE BROKE OFF (AT THE VERY TIP). THE WIRE TIP WAS RETRIEVED AFTER THE SKIN WAS NICKED FROM A SURGEON. THE SURGEON WAS ABLE TO VISUALIZE THE WIRE TIP FRAGMENT WITHIN THE VEIN, JUST UNDER THE SKIN. THE SURGEON WAS THEN ABLE TO REMOVE THE WIRE WITH HEMOSTATS WITHOUT ANY HARM TO THE PATIENT. TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5115904. THE EVENT DESCRIPTION STATES THAT IT WAS UNCLEAR HOW T

  Patient problems: Foreign Body In Patient; Vascular Dissection

  MAUDE report 16740808 ↗
• InjuryOct 26, 2022Material Separation; Material Separation

  TERUMO MEDICAL RECEIVED AN FDA MEDWATCH REPORT # MW5112081. THE EVENT DESCRIPTION STATES: "PATIENT REQUIRED A INARI THROMBECTOMY ON (B)(6) 2022 FOR EXTENSIVE PULMONARY EMBOLI IN BILATERAL AMIN PULMONARY ARTERIES. ON (B)(6) ON CTAP METALLIC FOREIGN BODY WAS SEEN IN THE RIGHT EXTERNAL ILIAC VEIN- ICU NOTES STATE "CARDIOLOGY AWARE DISCUSSED WITH PATIENT THAT PIECE OF WIRE BROKE OFF IN THROMBUS." PER CARDIOLOGY, WILL KEEP PATIENT ON LIFE LONG NOAC TO AVOID FUTURE THROMBUS AROUND THE WIRE. PATIENT EXPIRED ON (B)(6) 2022 AFTER GOING INTO PEA ARREST. PHYSICIAN INTERVIEW OCCURRED AND HE DOES NOT BELIEVE THIS EVENT CAUSED/CONTRIBUTED TO PATIENT'S DEATH. FDA SAFETY REPORT ID# (B)(4)." ADDITIONAL INFORMATION WAS RECEIVED ON 09/30/2022: THE INITIAL PROCEDURE WAS AN INARI THROMBECTOMY AND IT WAS PERFORMED ON (B)(6) 2022. THE DATE OF THE PATIENT'S DEATH WAS (B)(6) 2022. THE PHYSICIAN STATED THAT HE DID NOT FEEL THAT THE WIRE CONTRIBUTED TO THE PATIENT'S DEATH BECAUSE THE PATIENT ALREADY HAD BLOOD CLOTS PRIOR TO THE EVENT. THE PATIENT HAD A HISTORY OF OBESITY AND MARIJUANA DEPENDENCY. DIAGNOSED (DX) IN HOSPITAL WITH BILATERAL PULMONARY EMBOLISM'S (P.E.'S). THE PATIENT (PT) WAS 29 YEARS OLD AND DE

  Patient problems: Foreign Body In Patient; Thrombosis/Thrombus

  MAUDE report 15676797 ↗
• InjuryOct 14, 2019Break; Break

  UF MEDWATCH WAS RECEIVED ON (B)(6)2019. THE REPORT STATED "THE EVENT OCCURRED DURING A CARDIAC CATHETERIZATION PROCEDURE. WHEN ATTEMPTING TO OBTAIN RIGHT FEMORAL ACCESS WITH A 6FR TERUMO PINNACLE SHEATH, THE GUIDEWIRE WAS WITHDRAWN THROUGH THE ACCESS NEEDLE AND WAS SHEARED. THIS WAS RECOGNIZED IMMEDIATELY . THE END OF THE GUIDEWIRE REPORTEDLY UNRAVELED AND WAS STRETCHED OUT. THE STAFF REPORTED THE WIRE WAS NOT FRACTURED."

  Patient problems: No Code Available

  MAUDE report 9186320 ↗
• MalfunctionJan 29, 2019Break; Break

  THE USER FACILITY REPORTED WHEN THE PHYSICIAN WAS REMOVING THE IK SHEATH FROM THE RIGHT FEMORAL ARTERY, THE WIRE WAS SHREDDED. RADIAL APPROACH WAS PERFORMED AND SUCCESSFUL PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED. THE BLOOD LOSS WAS LESS THAN 250CC'S. THE PATIENT WAS IN STABLE CONDITION. THERE WERE NO OTHER DEVICES OR EQUIPMENT USED WITH THE REPORTED PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON JANUARY 18, 2019. THE WIRE UNRAVELED. THE PROCEDURE WAS COMPLETED.

  Patient problems: Blood Loss

  MAUDE report 8285475 ↗
• MalfunctionJun 25, 2018Fluid/Blood Leak; Fluid/Blood Leak

  THE USER FACILITY REPORTED THAT DURING A PERIPHERAL A IK DEVICE WAS USED. THE SHEATH WAS FLUSHED AND THE WATER SEEMED TO COME OUT OF NUMEROUS HOLES. THE DEVICE WAS NOT USED ON THE PATIENT. A SECOND DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT ISSUES. ADDITIONAL INFORMATION WAS RECEIVED ON 6/14/18: IT WAS REPORTED THAT SALINE SHOT OUT THE SIDES OF THE SHEATH. NO OTHER DAMAGES WERE FOUND ON THE DEVICE. THERE WAS NO BLOOD LOSS DUE TO THIS EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7635662 ↗
• MalfunctionAug 28, 2017Unraveled Material; Unraveled Material

  THE USER FACILITY REPORTED THAT THE .021 WIRE UNRAVELED AT THE DISTAL END; HOWEVER, THOSE PARTS WERE RETRIEVED FROM THE PATIENT. NO PATIENT INJURY WAS REPORTED. IT WAS REPORTED THE PROCEDURE OUTCOME WAS GOOD. IT WAS REPORTED THE PATIENT CONDITION WAS STABLE. AN RSS701 PINNACLE WAS USED WITH THE PRODUCT. ADDITIONAL INFORMATION WAS RECEIVED ON AUGUST 4, 2017. THERE WAS NO BLOOD LOSS. NO SURGICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6824191 ↗