MAUDE Adverse Event Report: TERUMO MEDICAL CORP. TERUMO PINNACLE R/O II INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number RSB803

Device Problems Entrapment of Device (1212); Fracture (1260)

Patient Problem Foreign Body In Patient (2687)

Event Date 07/13/2021

Event Type  Injury  

Event Description

Terumo pinnacle r/o ii introducer sheath with radiopaque maker 8 french 25 cm fractured during an endovascular procedure resulting in a retained foreign body.The patient required exploratory surgery and removal of the retained foreign body.Fda safety report id # (b)(4).

• Brand Name: TERUMO PINNACLE R/O II INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.; elkton MD 21921
• MDR Report Key: 12252466
• MDR Text Key: 264482623
• Report Number: MW5102858
• Device Sequence Number: 1
• Product Code: DYB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 07/27/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2023
• Device Model Number: RSB803
• Device Catalogue Number: RSB803
• Device Lot Number: 0000035077
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 67 YR