MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE PRECISION ACCESS SYSTEM; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Weight - (b)(6) kg.Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.A review of the device history record of the product code/lot# combination was conducted with no findings.[mw5078309.Pdf].
Event or Problem Description
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 successful.
Additional Manufacturer Narrative
This report is being submitted as follow up 2 to 1).One 0.021" guidewire was returned in two pieces for evaluation.No other accessory components were returned.The section containing the distal "floppy" end measured 2.5 cm.The coils on this portion did not unravel.The proximal section measured 40 cm.There was a significant portion of the wire uncoiled.Microscopy inspection of the unraveled sections and fracture points revealed that the fracture point appeared cut.The complaint can be confirmed.There is no indication that this event was related to a device defect or malfunction and the exact cause cannot be definitively determined.From the complaint description, the physician inserted the guidewire into the needle.When the physician encountered resistance they withdrew the guidewire through the needle.This is directly against the ifu and likely led to the breakage that was observed.The ifu states: "when using metal needle cannula do not withdraw the guidewire back into the cannula as shearing of the guidewire may result.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device return date.The actual device has been returned for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.

• Brand Name: PINNACLE PRECISION ACCESS SYSTEM
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7734328
• Report Number: 1118880-2018-00076
• Device Sequence Number: 13641239
• Product Code: DYB
• UDI-Device Identifier: 00389701010762
• UDI-Public: 00389701010762
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-4160
• Device Lot Number: WD21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2018
• Initial Date Received by Manufacturer: 07/18/2018
• Supplement Date Received by Manufacturer: 08/01/2018; 08/10/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/01/2018; 08/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ARGON ARTERIAL NEEDLE 21 GA X 1"
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 5 YR
• Patient Weight: 22