MAUDE Adverse Event Report: TERUMO MEDICAL CORPORATION TERUMO PINNACLE PRECISION ACCESS SYSTEM INTRODUCER SHEATH; INTRODUCER, CATHETER

Model Number 70-5165

Device Problems Entrapment of Device (1212); Material Fragmentation (1261)

Patient Problems Device Embedded In Tissue or Plaque (3165); Foreign Body Embolism (4439)

Event Date 12/05/2022

Event Type  Injury  

Event Description

Patient was admitted for outpatient interventional radiology (ir) for staged procedures.At the completion of the arteriogram, embolization prior to cryoablation, a small metallic foreign body was seen persisting in the region of intervention on review of imaging films.After cessation of the procedure, separate radiographs of the pelvis and right hip were obtained, as well as a focused ultrasound, demonstrating an apparent retained section of wire within the subcutaneous tissues, superficial to the right femoral artery and vein, and normal flow was established in the right common femoral artery and vein.Retrieval was felt to be more traumatic than the potential for complications, and therefore no retrieval attempt was made at the time.Subsequent attempt to remove the foreign body at a later date was unsuccessful.

• Brand Name: TERUMO PINNACLE PRECISION ACCESS SYSTEM INTRODUCER SHEATH
• Type of Device: INTRODUCER, CATHETER
• Manufacturer (Section D): TERUMO MEDICAL CORPORATION; elkton MD 21921
• MDR Report Key: 16504440
• MDR Text Key: 311013428
• Report Number: MW5115543
• 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: 03/03/2023

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: 02/01/2024
• Device Model Number: 70-5165
• Device Catalogue Number: 70-5165
• Device Lot Number: 0000063334
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 86 KG
• Patient Race: White