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

Model Number	RSS702
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/11/2026
Type of Reportable Event	Malfunction
Event or Problem Description
At hospital, patient came for outpatient fistulagram on lower left arm.At the end of the case, access sheath 7f was removed from patient.After removal, it was noted that only a partial piece was removed.After assessing, patient brought to or to open fistula and remove retained piece of sheath.Removed broken piece of sheath retained by biomed.It was noted by staff that patient had metal stent in upper left arm.Physician noted that it did not impact sheath removal.

• Brand Name: PINNACLE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.; 950 elkton blvd.; elkton MD 21921
• MDR Report Key: 24625719
• Report Number: 24625719
• Device Sequence Number: 18395937
• Product Code: DYB
• UDI-Device Identifier: 00389701007489
• UDI-Public: (01)00389701007489
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/16/2026
• Report Date (Section F): 03/16/2026

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 Model Number: RSS702
• Device Catalogue Number: RSS702
• Device Lot Number: 0001025006 OR 0001206652
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 03/18/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/18/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown
• Date Report Sent to FDA: 03/16/2026