MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 6F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA6IMA
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: received for analysis was one la6ima 6f launcher guide catheter with original packaging from the pouch with lot number 0007757890.The box and the die card were not returned.The catheter was received with a piece of the tip material slightly attached to the distal catheter.Visual inspection under magnification detected some pieces of the white tip remained on the edges of the shaft, the blue inner layer appears stretched likely indicating pull force applied to the tip.Pieces or the remaining parts of the tip were not returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A la6ima launcher guide catheter was attempted to be used.There was no damage noted to the device packaging.It is reported that the catheter tip completely detached when inserting it into the 6f non-mdt sheath.The tip of a second catheter was then checked and when gently pressed the tip completely detached from the catheter.No patient injury is reported.The procedure was successfully completed using another launcher of the same size.At the facility the catheters are stored in the nurse's room in a closed cabinet, hanging with restricted access.There is a window in the room but the catheters are not exposed to light since the cabinet is closed with wooden doors.The catheters are removed from the boxes and left hanging.The room temperature is approximately 20 degrees.Although it was reported that the devices were not used in the patient the damage observed indicates that an attempt may have been made to insert the devices into the introducer.

• Brand Name: LAUNCHER 6F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8925864
• Report Number: 1220452-2019-00102
• Device Sequence Number: 254071
• Product Code: DQY
• UDI-Device Identifier: 00613994821089
• UDI-Public: 00613994821089
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/23/2019

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: 09/21/2017
• Device Model Number: LA6IMA
• Device Catalogue Number: LA6IMA
• Device Lot Number: 0007757890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2018
• Initial Report FDA Received Date: 08/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1