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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Claudication (2550)
Date of Event	02/12/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).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.[mw5084318.Pdf].
Event or Problem Description
This report is being submitted in response to user facility medwatch report # mw5084318 was received from the fda on march 11, 2019.The event description states the following: a patient was admitted with a right lower leg claudication for angiography and a possible pta (percutaneous transluminal angioplasty), access via the left femoral artery, was technically challenging.Due to the extensively calcified vessels, resulting in retention of the distal tip of the angiography microwire.The patient will undergo a right lower extremity endartectomy (to address claudication) with open surgical removal of the microwire at a future date.The patient was hospitalized with a surgical follow up planned.

• 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: 8452619
• Report Number: 1118880-2019-00041
• Device Sequence Number: 13501057
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: 00389701010779
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K111606
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 03/26/2019

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: 70-5160
• Device Lot Number: WL26
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention