MAUDE Adverse Event Report: COVIDIEN LP - SUPERDIMENSION INC EDGE CATHETER SYSTEM; SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED

Model Number SD300LG

Device Problems Detachment Of Device Component (1104); Unstable (1667)

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

Event Date 06/07/2017

Event Type  malfunction  

Manufacturer Narrative

Evaluation of the locatable guide found that the tip was not secured during construction of the device and the crimp length was not adequate for proper crimping as crimped in manufacturing.An internal corrective action has been initiated.If information is provided in the future, a supplemental report will be issued.

Event Description

The locatable guide was returned with another device for analysis and the locatable guide was found with the sensor tip detached from the device.There was no report of patient injury, death, or other serious adverse event.

• Brand Name: EDGE CATHETER SYSTEM
• Type of Device: SYSTEM, X-RAY, TOMOGRAPHY, COMPUTED
• Manufacturer (Section D): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer (Section G): COVIDIEN LP - SUPERDIMENSION INC; 161 cheshire lane, suite 100; plymouth MN 55441
• Manufacturer Contact: sharon murphy ; 161 cheshire lane; suite 100; minneapolis, MN 55441 ; 2034925267
• MDR Report Key: 6995855
• MDR Text Key: 91217864
• Report Number: 3004962788-2017-05110
• Device Sequence Number: 1
• Product Code: JAK
• UDI-Device Identifier: 10884521199514
• UDI-Public: 10884521199514
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K102604
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD300LG
• Device Catalogue Number: SD300LG
• Device Lot Number: EK05469
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2017
• Date Manufacturer Received: 10/16/2017
• Date Device Manufactured: 03/10/2016
• 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): Other