MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE R/O II AND ACCESSORIES; 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	05/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.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/ potential lot# combination was conducted with no findings.
Event or Problem Description
The user facility reported after the doctor had an issue with the 7fr pinnacle.The second hub or alternate hub had been breaking.The patient was in stable condition.The procedure outcome was successful.There was no blood loss.There was no patient injury, medical/surgical intervention required.Additional information was received on 19may2020: the procedure was a peripheral angiogram.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to update section h3, and to provide the completed investigation results.One 7fr introducer sheath was received for product evaluation.A blood like substance was noted throughout the side tube and the sheath hub.Visual inspection revealed a crack on one of the luer connections.This luer connection was viewed under microscope and a large crack was noted.Based on the provided information and investigation results there is no evidence that this event was related to a device defect or malfunction.However, the exact cause of the reported event cannot be definitively determined based on the available information.This reported event has been reassessed and has been deemed not reportable.

• Brand Name: PINNACLE R/O II AND ACCESSORIES
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton, md
• MDR Report Key: 10148937
• Report Number: 1118880-2020-00125
• Device Sequence Number: 14013351
• Product Code: DYB
• UDI-Device Identifier: 00389701007571
• UDI-Public: 00389701007571
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K003424
• 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): 06/12/2020

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: 06/30/2022
• Device Model Number: N/A
• Device Catalogue Number: RSB702
• Device Lot Number: YA0113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2020
• Initial Date Received by Manufacturer: 05/18/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1