MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE R/O II AND ACCESSORIES; INTRODUCER, CATHETER

Model Number	N/A
Medical Device Problem Code	Device Markings/Labelling Problem (2911)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	11/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.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 the physician requested a ik 10cm roii sheath however a 6cm roii sheath was opened and inadvertently utilized.Due to the shorter sheath length the sheath came out of the artery and a surgical cut-down was required to close the vessel.The physician stated that the packaging contains small writing making it difficult for the staff to see what product they are opening.The patient was reported to be in stable condition.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide additional information and the completed investigation.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.
Event or Problem Description
Additional information was received on november 20, 2018.The blood loss was reported to be unknown, however, a blood transfusion was required.The procedure was completed successfully.

• Brand Name: PINNACLE R/O II AND ACCESSORIES
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8077255
• Report Number: 1118880-2018-00170
• Device Sequence Number: 1691740
• Product Code: DYB
• UDI-Device Identifier: 00389701007533
• UDI-Public: 00389701007533
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2018

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: 12/31/2019
• Device Model Number: N/A
• Device Catalogue Number: RSB601
• Device Lot Number: VH2613
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/08/2018
• Supplement Date Received by Manufacturer: 11/20/2018
• Initial Report FDA Received Date: 11/16/2018
• Supplement Report FDA Received Date: 11/28/2018
• 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: 76 YR