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

Model Number	RSS706
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
E3: occupation: (b)(6).The actual device has been returned.The investigation is currently ongoing.A follow-up report will be submitted once the investigation is complete.
Event or Problem Description
The user facility reported that the 7fr sheath was used and a perclose was used at the end of the case.The sheath broke and only approximately 1in of the sheath with the hub attached is being returned as that is what came out of the patient.The other 24cm was left in the patient.They left ep and were sent up to the cath lab to have it removed.All was successfully removed from the patient.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to update section h3, and to provide the completed investigation results.One 7fr ik sheath and packaging were returned to terumo medical corporation for assessment.The sample was subject to visual analysis.The sheath is separated 2.8-3cm from the sheath hub.The broken end of the sheath is torn and stretched.The complaint can be confirmed for a sheath separation.With limited information, the exact root cause cannot be determined.The likely root cause is the sheath was withdrawn in the face of resistance based on the state of the returned sample.The end of the sheath is stretched and torn likely due to pulling the sheath until it separated.Review of device history record (dhr) showed there were no issues noted during the 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 hazard based risk table (hbrt).

• Brand Name: PINNACLE
• Common Device Name: INTRODUCER, CATHETER
• 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: stephanie handy ; 950 elkton blvd; elkton, MD 21921 ; 9499890491
• MDR Report Key: 20700724
• Report Number: 1118880-2024-00171
• Device Sequence Number: 3757070
• Product Code: DYB
• UDI-Device Identifier: 00389701007724
• UDI-Public: (01)00389701007724(10)261101(10)0000603753
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: ZL954234
• 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): 11/15/2024

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 Model Number: RSS706
• Device Catalogue Number: RSS706
• Device Lot Number: 0000603753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/17/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 12/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/23/2024
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 75 YR
• Patient Sex: Male