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

Model Number FR. 5, 10 CM NITINOL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem Claudication (2550)

Event Date 02/12/2019

Event Type  Injury  

Event Description

Patient admitted with (r) le claudication for angiography and possible pta.Access via the (l) femoral artery was technically challenging d/t extensively calcified vessels, resulting in retention of the distal tip of the angiography microwire.Patient will under rle endarterectomy (to address claudication) with open surgical removal of microwire at a future date.

• Brand Name: TERUMO PINNACLE PRECISION ACCESS SYSTEM
• Type of Device: PINNACLE MICROWIRE INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; elkton MD 21921
• MDR Report Key: 8366700
• MDR Text Key: 137358666
• Report Number: MW5084318
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: FR. 5, 10 CM NITINOL
• Device Catalogue Number: 70-5160
• Device Lot Number: WL26
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 75 YR