MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION PINNACLE ROII HIFLOW INTRODUCER SHEATH; INTRODUCER, SHEATH

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that the involved ik device sheath began to leak blood from the sheath at the connection between the orange hub and the white sheath.Procedure was completed with this sheath.The patient was not injured, medical or surgical intervention was not required.The event occurred intra-operative.The estimated blood loss was less than 250cc.Patient was in stable condition.There was not a direct allegation that the reported device caused or contributed to patient injury and/or need for medical intervention.
Additional Manufacturer Narrative
D6a: implanted date: device was not implanted.D6b: explanted date: device was not explanted.E3: occupation: lead tech.A review of the device history record of the product code/lot# combination was conducted with no findings.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.
Additional Manufacturer Narrative
This report is being submitted as follow-up no.1 to update section h3, to provide the completed investigation results and to report that this reported event has been reassessed and deemed not reportable based upon the investigation of the actual sample.Inspection of the returned sample upon receipt found that the complaint cannot be confirmed for leakage at the sheath hub because the returned sample did not leak anywhere along the sheath and no damage or deformities were found.The likely root cause for the deformed sheath tip was likely during insertion into the vasculature or during the use of concomitant devices.; therefore, this event is currently deemed a non-reportable event.One 7 fr ik sheath was returned for assessment.The sample was subject to visual analysis.No damage or deformities were noted on the sheath or sheath hub.The sheath tip is deformed.The sample was subject to leak testing.For leak testing, the ik sheath distal end was connected to leak testing equipment providing constant air pressure at 4.3 psi to simulate low pressure leak testing.The device was pressurized and placed under a water bath to visualize bubble formation to test for the presence of a leak.The dilator was inserted to check for a leak at the cross-cut valve.The sample did not leak during the insertion of the dilator.The leak testing equipment was connected to the 3wsc to check for the presence of a leak at the sheath hub.No leaks were observed from the sheath or sheath hub.The complaint cannot be confirmed for leakage at the sheath hub because the returned sample did not leak anywhere along the sheath and no damage or deformities were found.The exact root cause cannot be determined.It is unknown the cause of the leak the user experienced.The sheath tip likely deformed during insertion into the vasculature or during the use of concomitant devices.Review of device history record (dhr) showed there were no issues noted during manufacture of the product that could have contributed to this complaint condition.Currently no action is recommended since the risk evaluation is within the predetermined limits in the design failure mode and effects analysis (dfmea).

• Brand Name: PINNACLE ROII HIFLOW INTRODUCER SHEATH
• Common Device Name: INTRODUCER, SHEATH
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer (Section G): TERUMO MEDICAL CORPORATION; 950 elkton blvd.; elkton MD 21921
• Manufacturer Contact: gina digioia ; 950 elkton blvd; elkton, MD 21921 ; 6402040886
• MDR Report Key: 17234794
• Report Number: 1118880-2023-00321
• Device Sequence Number: 20244486
• Product Code: DYB
• UDI-Device Identifier: 00389701008295
• UDI-Public: 00389701008295
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K062446
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2023

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: 08/01/2025
• Device Model Number: N/A
• Device Catalogue Number: RSB704H
• Device Lot Number: 0000306223
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/30/2023
• Supplement Date Received by Manufacturer: 07/18/2023
• Initial Report FDA Received Date: 06/29/2023
• Supplement Report FDA Received Date: 08/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/07/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: BARD CONQUEST 40, 10MM X 40M & BALLOON.
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Weight: 73 KG
• Patient Ethnicity: Hispanic
• Patient Race: White