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

Model Number	RSS602
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); Embolism/Embolus (4438)
Date of Event	01/03/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A3b: gender: n/a.D6a: implanted date: device was not implanted d6b: explanted date: device was not explanted 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.
Event or Problem Description
Terumo medical received medwatch # (b)(4).The event description states that: an elderly female with persistent atrial fibrillation with rapid ventricular response underwent an electrophysiology study with drug stimulation and ablation of atrial fibrillation of the pulmonary vein.Upon removal of the left femoral arterial sheath, the distal portion of the sheath was retained and could not be accessed percutaneously.The provider elected to leave the retained portion in place.There was evidence of good hemostasis noted on ultrasound as well as following manual compression.The sl2 sheath was removed and left the short 8-french sheath in place on the right side.Additionally, we placed a right femoral arterial 5-french sheath for blood pressure monitoring.At this point, we concluded the procedure.The patient was extubated and transported to the holding area for further observation and bed rest.A surgical consultation was obtained, and the patient was taken to the operating room for emergent exploration of the left common femoral artery and the left common femoral vein, with repair of the left common femoral artery in two locations anteriorly and posteriorly, and exploration of the left common femoral vein with a venotomy and extraction of a 6 cm intravascular catheter, followed by repair of the left common femoral vein.An intraoperative vascular ultrasound of the bilateral external iliac artery and vein and the bilateral common femoral artery and vein, as well as the left superficial femoral and profunda arteries, was performed.The original intended procedure was an electrophysiology study with drug stimulation and ablation of atrial fibrillation of the pulmonary vein.No other therapies were administered.Additional information received on 14 jan 2025: the 6-french sheath separated/broke, leaving the distal portion inside the left femoral artery.Ethicon 3-0 coated vicryl suture with sh (small half-circle) needle was being used with the 6-french sheath when it was inserted.The separated/broken portion of the sheath is no longer in the patient.
Additional Manufacturer Narrative
This report is being sent as follow-up no.1 to provide the completed investigation results.The actual device was not returned; therefore, an evaluation of the actual device was unable to be conducted.The complaint cannot be confirmed for a sheath breakage because a sample was not returned for assessment.Without a sample, the exact root cause cannot be determined.However, with limited information regarding the procedure, the cause of the sheath breakage cannot be determined.The device history record was reviewed to ensure that each manufacturing and inspection operation was performed.The review determined the process was performed and completed in accordance with terumo medical corporation specifications and procedures and the device was released in a conforming state.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: 21360210
• Report Number: 1118880-2025-00004
• Device Sequence Number: 18252253
• Product Code: DYB
• UDI-Device Identifier: 00389701007472
• UDI-Public: (01)00389701007472(17)261201(10)0000638203
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K954234
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2025

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: RSS602
• Device Catalogue Number: RSS602
• Device Lot Number: 0000638203
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2024
• 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; Other
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 75 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White