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

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	11/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.The actual device has not 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.[uf medwatch (b)(4)].
Event or Problem Description
Terumo medical received an fda medwatch with additional information on april 5, 2019.The event description states: after establishing access, the doctor was trying to feed the introducer into the sheath.The doctor was unable to advance due to the tip being broken.The broken item was removed from surgical field and a new sheath set opened to sterile field.The patient procedure was a atherosclerosis of native artery of both lower extremities with rest pain and tissue loss.Additional information was received april 24, 2019: there was no intervention required for the patient.It was not confirmed if the actual tip of the device broke off, or was actually damaged causing the issue with advancement.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide an update and 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 RO II INTRODUCER SHEATH
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 8556733
• Report Number: 1118880-2019-00089
• Device Sequence Number: 19410460
• Product Code: DYB
• UDI-Device Identifier: 00389701009315
• UDI-Public: 00389701009315
• 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: User Facility
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2019

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: 02/28/2021
• Device Model Number: N/A
• Device Catalogue Number: RSB502
• Device Lot Number: WL1913
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 05/09/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 78 YR
• Patient Weight: 63