MAUDE Adverse Event Report: SCANLAN SCANLAN TUNNELER SHEATH AND BULLET TIP

Model Number REF 9009-18

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

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/21/2017

Event Type  Injury  

Event Description

Tip of the tunneling catheter - green/scanlan in the soft tissue of the left thigh.Went to operating room immediately after donning appropriate operating room attire, discussed it with surgeon dr.(b)(6) who felt the risk/benefit analysis - risk of removing it with additional soft tissue dissection vs leaving it in as sterile object - was in favor of leaving it in.High risk of bleeding and hematoma formation if attempts were made to remove it, since the patient was anticoagulated due to heparin.Per dr.(b)(6) the unintended retention of this foreign object was due to presence of scar tissue (pt's had 9 previous procedures on this leg per his wife), and was not due to technique or equipment failure.Discussed with wife who agreed to leaving fb in place.

• Brand Name: SCANLAN TUNNELER SHEATH AND BULLET TIP
• Type of Device: SCANLAN TUNNELER SHEATH AND BULLET TIP
• Manufacturer (Section D): SCANLAN; one scanlan plaza; st. paul MN 55107
• MDR Report Key: 6521893
• MDR Text Key: 73892452
• Report Number: MW5069326
• Device Sequence Number: 1
• Product Code: DWS
• 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: 04/19/2017

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: 12/16/2021
• Device Model Number: REF 9009-18
• Device Lot Number: 5757001
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/24/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 90 YR