MAUDE Adverse Event Report: SCANLAN INTERNATIONAL INC SCANLAN VASCULAR TUNNELER SHEATHS AND BULLET TIPS; INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number 9009-22

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 12/09/2020

Event Type  malfunction  

Event Description

Used scanlan sheath to tunneled arteograft in the arm and the bullet tip broke apart while in use.All pieces retrieved by the surgeon.

• Brand Name: SCANLAN VASCULAR TUNNELER SHEATHS AND BULLET TIPS
• Type of Device: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): SCANLAN INTERNATIONAL INC; 1 scanlan plz; saint paul MN 55107
• MDR Report Key: 11036212
• MDR Text Key: 222305896
• Report Number: 11036212
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/15/2020

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 Operator: No Information
• Device Model Number: 9009-22
• Device Catalogue Number: 9009-22
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/15/2020
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2020
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 17520 DA
• Patient Weight: 76