MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE RO II INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was not implanted.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 the ik sheath was kinked out of the package.The product never touched the patient.The procedure completed successfully with a second sheath.There was no patient injury or medical intervention required, the patient was in stable condition.Additional information was received on september 17, 2018.The procedure being performed was a peripheral intervention.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the completed investigation.One 5fr ik sheath and dilator were received for product evaluation.The device was returned out of the package and a part of the label was returned separately.Visual inspection revealed that there were no gross visual anomalies noted with the dilator.The sheath was examined, and there was a kink in the sheath near the hub.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.

• Brand Name: PINNACLE RO II INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 7913866
• Report Number: 1118880-2018-00138
• Device Sequence Number: 2255635
• Product Code: DYB
• UDI-Device Identifier: 00389701009384
• UDI-Public: 00389701009384
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K082847
• 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): 09/27/2018

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: No Information
• Device Expiration Date: 12/31/2020
• Device Model Number: N/A
• Device Catalogue Number: RSB512
• Device Lot Number: WH2513
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2018
• Initial Date Received by Manufacturer: 09/14/2018
• Supplement Date Received by Manufacturer: 10/18/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 10/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 67 YR