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

Model Number	N/A
Medical Device Problem Codes	Difficult to Flush (1251); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/22/2018
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 for evaluation.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code has been referenced in the conclusions.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 while using a precision device the sheath would not flush in the patient.The sheath was removed and another hole was noticed where saline was spraying out.They used another precision and it worked fine.The patient was reported to be fine.The procedure outcome was a success.Additional information was received on 8/24/2018: the procedure was a pedal case.The saline was spraying through a sheath.Additional information was received on 8/27/2018: there was a tiny hole on the lateral portion of the sheath.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation results.The evaluation of the actual device could not be conducted due to the device not being returned.With no device return, 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: 7856069
• Report Number: 1118880-2018-00107
• Device Sequence Number: 11379857
• Product Code: DYB
• UDI-Device Identifier: 00389701010762
• UDI-Public: 00389701010762
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 09/07/2018

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: 08/31/2020
• Device Model Number: N/A
• Device Catalogue Number: 70-4160
• Device Lot Number: WD21
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2018
• Supplement Date Received by Manufacturer: 10/03/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 10/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1