MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. TUNNELER SHEATH, SMALL GREEN; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 9009-18

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Laceration(s) (1946); Foreign Body In Patient (2687)

Event Date 04/18/2022

Event Type  Injury  

Event Description

Patient was receiving a femoral/popliteal bypass on his right leg using a sheath with bullet tip (scanlan ref 9009-18).When the surgeon pulled back on the tunneler the bullet tip came off and became lodged under the femur in the muscle.After several attempts to retrieve the bullet tip, an additional surgeon and fluoroscopy was used to locate and remove the tip.The patient experienced an additional incision on the outside right thigh in order to retrieve the tip.We currently use this plastic tunneler because manufacturers no longer make the metal ones we previously used.Fda safety report id # (b)(4).

• Brand Name: TUNNELER SHEATH, SMALL GREEN
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; st. paul MN 55107
• MDR Report Key: 14675786
• MDR Text Key: 293962778
• Report Number: MW5110251
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 9009-18
• Device Catalogue Number: 9009-18
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Sex: Male
• Patient Weight: 101 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White