MAUDE Adverse Event Report: COVIDIEN, FORMERLY US SURGICAL A DIVISON 7FR PEEL-AWAY SHEATH INTRODUCER KIT; PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER

Model Number	120089
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Out-Of-Box Failure (2311)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/30/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
According to the reporter, during a port implantation, the sheath fractured.Problem was discovered prior to use.Device was not used on the patient and there was no patient harm.
Additional Manufacturer Narrative
Evaluation summary: post market vigilance (pmv) led an evaluation one device along with a photograph opened by the account.This evaluation was based on a technical review of all data received from the site, a pmv review of manufacturing records, a pmv review of complaint trends, and an evaluation of the returned device.The photograph of the device was showed the package open.The tubing was observed intact.The introducer sheath was deformed, and the sheath was split long its length.Visual inspection of the returned device noted the sheath was damaged at the distal end along the edge.Replication of this condition may occur when the instrument is handled roughly during insertion and if the device is manipulated roughly using another instrument.A review of the appropriate device history record indicates this device lot number was released meeting all quality specifications subsequently, the complaint data did not display an increased trend.Should new information become available, the file will be re-opened and the investigation summary will be amended as appropriate.

• Brand Name: 7FR PEEL-AWAY SHEATH INTRODUCER KIT
• Common Device Name: PERCUTANEOUS, IMPLANTED, LONG-TERM INTRAVASCULAR CATHETER
• Manufacturer (Section D): COVIDIEN, FORMERLY US SURGICAL A DIVISON; 60 middletown ave; north haven CT 06473
• MDR Report Key: 5569588
• Report Number: 1219930-2016-00317
• Device Sequence Number: 16259176
• Product Code: LJS
• UDI-Device Identifier: 10884521099289
• UDI-Public: (01)10884521099289
• Combination Product (Y/N): N
• PMA/510(K) Number: K961856
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2016

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2019
• Device Model Number: 120089
• Device Catalogue Number: 120089
• Device Lot Number: N4E0356X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/31/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/12/2016
• Supplement Report FDA Received Date: 05/03/2016
• Patient Sequence Number: 1