MAUDE Adverse Event Report: TERUMO MEDICAL CORP. PINNACLE GLIDESHEATH SLENDER FRENCH # 5; INTRODUCER, CATHETER

Lot Number 0000011031

Device Problem Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/17/2021

Event Type  Injury  

Event Description

Patient presented for right radial artery access under ultrasound guidance in cath lab during hospitalization.After the procedure, it was discovered that patient had retained a piece of the terumo french # 4 sheath.Upon assessment and attempts to retrieve, it was determined that the sheath would remain, as there was no harm to patient's vessel and good flow to the arm.No further issues noted, and patient discharged in good condition.Fda safety report id # (b)(4).

• Brand Name: PINNACLE GLIDESHEATH SLENDER FRENCH # 5
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.
• MDR Report Key: 11435185
• MDR Text Key: 238857065
• Report Number: MW5099825
• Device Sequence Number: 1
• Product Code: DYB
• UDI-Device Identifier: 389701012049
• UDI-Public: 01389701012049
• 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: 03/03/2021

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2023
• Device Lot Number: 0000011031
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/05/2021
• 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): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 50