MAUDE Adverse Event Report: TERUMO INTRODUCER SHEATH 6FR

Lot Number 0000188990

Device Problems Break (1069); Entrapment of Device (1212); Failure to Advance (2524)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/23/2022

Event Type  Injury  

Event Description

Physician could not advance sheath guide wire.Wire removed from introducer needle.Tip of wire stayed with patient.Vascular surgeon documented that foreign body was left in place as he believe the risk of this foreign body is extremely small for any long-term consequences or even acute complications.Much less than the risk of placing this patient under general anesthesia patient was discharged home on (b)(6) 2022.See scanned page.

• Brand Name: INTRODUCER SHEATH 6FR
• Type of Device: INTRODUCER SHEATH 6FR
• Manufacturer (Section D): TERUMO
• MDR Report Key: 15550130
• MDR Text Key: 301264687
• Report Number: 15550130
• 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: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2022

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
• Device Lot Number: 0000188990
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 09/23/2022
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/05/2022
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Life Threatening
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 105 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White