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

Model Number RSS902

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/14/2019

Event Type  Injury  

Event Description

Terumo pinnacle introducer sheath broke off inside the pt during procedure requiring surgical intervention to remove the sheath from the pt.Fda safety report id# (b)(4).

• Brand Name: TERUMO PINNACLE INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORP.
• MDR Report Key: 9445797
• MDR Text Key: 170281734
• Report Number: MW5091551
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• 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: 12/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: RSS902
• Device Catalogue Number: RSS902
• Device Lot Number: XE03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2019
• Is the Reporter a Health Professional?: No
• 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: 66 YR
• Patient Weight: 83