MAUDE Adverse Event Report: SCANLAN INTERNATIONAL, INC. SCANLAN VASCULAR TUNNELER SHEATH

Model Number 9009-16

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/25/2014

Event Type  malfunction  

Event Description

Tunneler was being used, and when pulling tunneler out, the tip came off in the pt's groin area.The tip was retrieved as reported.

Manufacturer Narrative

Returned product was examined.Our examination of the returned product revealed the sheath has been kinked during use.It is not known if a tunneler instrument was used with the sheath during the procedure, as is stipulated in the ifu.No further info regarding this occurrence is available from the user facility.

• Brand Name: SCANLAN VASCULAR TUNNELER SHEATH
• Type of Device: VASCULAR TUNNELER SHEATH
• Manufacturer (Section D): SCANLAN INTERNATIONAL, INC.; one scanlan plaza; st paul MN 55107
• Manufacturer Contact: mark watson ; one scanlan plaza; st paul, MN 55107 ; 6512980997
• MDR Report Key: 4226632
• MDR Text Key: 4994357
• Report Number: 2126670-2014-00001
• 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: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/25/2014

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: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: 9009-16
• Device Catalogue Number: 9009-16
• Device Lot Number: 5353901
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/22/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/26/2014
• Initial Date FDA Received: 10/25/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Weight: 103