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	No Code Available (3191)
Date of Event	09/19/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(4).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.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 when the physician attempted to gain femoral access and failed, he removed the ik precision needle and wire simultaneously.The needle was removed from the tissue track without issue, however the.021-inch nitinol wire snagged in the tissue track.When attempting to remove the wire, it became unraveled and broke.Forceps were used to pull the wire that remained in the tissue track out of the body.The patient was reported to be in stable condition.The procedure outcome was successful.There were no other devices or equipment being used with the reported product.Additional information was received on 22sept2019.The procedure performed was a left heart catheterization.The physician was satisfied that he had removed the wire using forceps.The procedure was completed with access being gained with an 18 gauge cook arterial needle and a standard pinnacle 6fr sheath.
Event or Problem Description
Uf medwatch was received on (b)(6)2019.The report stated "the event occurred during a cardiac catheterization procedure.When attempting to obtain right femoral access with a 6fr terumo pinnacle sheath, the guidewire was withdrawn through the access needle and was sheared.This was recognized immediately.The end of the guidewire reportedly unraveled and was stretched out.The staff reported the wire was not fractured.".
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information in section b5, update section h3, and to provide the completed investigation results.One 6fr introducer sheath guide wire and needle were returned for product evaluation.Visual inspection of the guidewire prior to decontamination revealed major uncoiling was observed at the distal floppy end.After decontamination, the guidewire was viewed under microscope to better see the uncoiling on the distal tip.The guidewire hydrophilic coating was not present starting at 261 mm from the proximal end weld.The major uncoiling on the guidewire starts at 400 mm from the proximal end.Scratch marks were also seen on the hydrophilic coating.The needle cannula was observed under microscope and no anomalies or damage was seen.The needle tip was also viewed under microscope and scratch marks can be seen on the bevel and the inside of the needle tip.Measurements of the guide wire were taken throughout hydrophilic coated portion and the diameter throughout the wire is 0.51 mm which is within the manufacturer specification of 0.51-0.54 mm.The inner diameter of the needle was measured at 0.56 mm and is within the manufacturer specification.Based on the provided information and investigation results, there is no definitive evidence that this event was related to a device defect or malfunction.Based on the investigation results the customer stated that he removed the needle and guidewire simultaneously which likely caused the hydrophilic coating to scratch off.This action likely exposed the coiled wire underneath and caused the major uncoiling of the device at the floppy distal tip.However, the exact cause of the reported event cannot be definitively determined based on the available information.

• 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: 9186320
• Report Number: 1118880-2019-00284
• Device Sequence Number: 16718848
• Product Code: DYB
• UDI-Device Identifier: 00389701010793
• UDI-Public: 00389701010793
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 10/14/2019

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: 10/31/2021
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: XF29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2019
• Initial Date Received by Manufacturer: 09/19/2019
• Supplement Date Received by Manufacturer: 10/25/2019
• Initial Report FDA Received Date: 10/14/2019
• Supplement Report FDA Received Date: 11/11/2019
• 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: Required Intervention
• Patient Age: 77 YR
• Patient Weight: 83