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

Model Number	N/A
Medical Device Problem Codes	Failure to Advance (2524); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/29/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.A review of the device history record of the product code/lot# combination was conducted with no findings.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
The user facility reported that the doctor was using a 6f precision sheath to gain right common femoral arterial access.The physician was not using an ultrasound.He used the precision needle to gain access, and after he visualized blood return, he then inserted the precision nitinol wire.Resistance was encountered and he tried to push through to advance the wire, however, he was unsuccessful.He then removed the wire and needle, and the wire was bent, however it was intact.The physician then attempted access again, with the same needle and wire.He still met resistance on inserting the wire.When he pulled the wire back, the wire became stuck on the bevel of the needle.He pulled harder on the wire and the wire became unraveled on the distal end.The bent portion of the wire was stuck on the bevel.The wire was removed in its entirety, however, the distal end was completely unwrapped.There was no piece of wire left behind or broken.A merit micro kit was opened for the wire to complete gaining access.The remainder of procedure was a success.There was no patient injury due to the unraveled wire, and the patient was reported to be in stable condition.

• 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: 8142420
• Report Number: 1118880-2018-00195
• Device Sequence Number: 204071
• Product Code: DYB
• UDI-Device Identifier: 00389701010786
• UDI-Public: 00389701010786
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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
• Report Date (Section B): 12/07/2018

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: WL12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/29/2018
• Initial Report FDA Received Date: 12/07/2018
• 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: WIRE FROM MERIT MICRO KIT
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR