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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597)
Date of Event	08/03/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device 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.
Event or Problem Description
The user facility reported that the ik wire was not advancing smoothly when the physician was obtaining access and advancing the wire into the needle.Upon trying to remove the wire it became stuck in the needle.The needle and wire were removed together and manual pressure was used at the site.A 18 gauge needle was used and a 6 fr pinnacle sheath was then inserted to complete the case successfully.The blood loss was less than 250 cc's.The patient is in stable condition.The procedure was completed successfully.Additional information was received on 8/8/18: the procedure was a left heart cardiac catheterization.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device returned date and to provide the completed investigation results.A 0.21" guidewire and 21g tapered needled was for evaluation.The guidewire and needle were subjected to visual analysis.The guidewire was returned wrapped in a coil.Visual inspection revealed bends in the guidewire.The outer diameter of the guidewire and inner diameter of the distal end of the needle were measured and confirmed to meet manufacture specification.Functional testing was conducted inserting the returned guidewire into the needle.There was resistance felt when the guidewire attempted to exit the distal end of the needle.The wire then became stuck in the needle.When the guidewire could not be advanced, it was withdrawn through the needle, which led to shearing of the guidewire.There is no evidence that this event was related to a device defect or malfunction.Based on the investigation results it is likely the bends in the guidewire contributed to the difficulty that was observed.However, the exact cause of the reported event cannot be definitively determined.

• 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: 7789495
• Report Number: 1118880-2018-00098
• Device Sequence Number: 2336373
• Product Code: DYB
• UDI-Device Identifier: 00389701010489
• UDI-Public: 00389701010489
• Combination Product (Y/N): N
• Initial Reporter State: KY
• 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
• Report Date (Section B): 08/16/2018

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: 03/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-6130
• Device Lot Number: VM18
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2018
• Initial Date Received by Manufacturer: 08/05/2018
• Supplement Date Received by Manufacturer: 08/17/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 08/29/2018
• 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: Required Intervention