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 Consequences Or Impact To Patient (2199)
Date of Event	01/22/2018
Type of Reportable Event	Malfunction
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 the dilator hub or handle broke off from the sheath as the md tried to remove dilator after the sheath insertion.The md had to remove the dilator with surgical forceps.Additional information was received on january 24, 2018.It was a peripheral angioplasty procedure.There was no blood loss or negative outcome of the procedure itself.No pieces or fragments were left behind, the physician was able to grasp the broken piece of dilator with some forceps and he pulled out the complete dilator.It seemed like the hub assembly from the dilator just snapped off at the base.The sheath performed as intended after the dilator was removed, and there were no issues or leaks, just the initial failure when it snapped off upon entry into the common femoral artery as the physician was removing the wire and dilator after getting access.There were other catheters and equipment used after the sheath was inserted.The patient was reported to be stable and the procedure outcome was positive.The scrub tech disposed the dilator and the broken off hub assembly into a bio hazard bag.

• 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: 7269782
• Report Number: 1118880-2018-00001
• Device Sequence Number: 19168247
• Product Code: DYB
• UDI-Device Identifier: 00389701010779
• UDI-Public: 00389701010779
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Type of Report: Initial
• Report Date (Section B): 02/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-6160
• Device Lot Number: VK23
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 87