MAUDE Adverse Event Report: ST. JUDE MEDICAL PEEL-AWAY INTRODUCER

Model Number 405104

Device Problems Separation Failure (2547); Device Operates Differently Than Expected (2913)

Patient Problem No Information (3190)

Event Date 09/06/2016

Event Type  Injury  

Event Description

Peel-away introducer produced by st.Jude medical, 6f ref# (b)(4), lot #5563789 did not peel away as it should.Upon completion of lead placement, implanting physician attempted to snap the hub which did not break away cleanly into two even parts.Instead of being able to "peel away" the introducer from the sheath, the item would not separate and had to be cut away from the lead.No damage done to the lead or adverse event noted.

• Brand Name: PEEL-AWAY INTRODUCER
• Type of Device: PEEL-AWAY INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL; plymouth MN 55442
• MDR Report Key: 5942433
• MDR Text Key: 54526168
• Report Number: MW5064646
• Device Sequence Number: 1
• Product Code: DYB
• 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: 09/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 405104
• Device Lot Number: 5563789
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 65 YR
• Patient Weight: 89