MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA7AL10
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: received for analysis was one 7fr launcher guide catheter.There was a detachment on the shaft of the catheter approx.12cm distal to the strain relief.The detached distal section was loaded into a non-medtronic introducer.Both sides of the detachment site were jagged and uneven, and the wire braiding was exposed.Evidence of excessive torquing on the proximal detached portion and on the distal portion, just distal to the tip of the introducer.The shaft of the catheter was flattened immediately distal to the introducer tip.A torsional kink was noted on the mid-shaft, with blood leaking through, indicating a tear in the material.Device could not be removed proximally from sheath due to flattening of the shaft distal to the tip of the introducer.It was removed by pulling distally.No other damage was evident to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 7f launcher guide catheter was used during a procedure.It was reported that the guide catheter separated in the proximal portion of the catheter.The device was inspected before use with no issues noted.Resistance was not noted during delivery.The device was not kinked and re-straightened during use.Both portions of the guide catheter were removed from the patient with no patient injury.

• Brand Name: LAUNCHER 7F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 11036944
• Report Number: 1220452-2020-00101
• Device Sequence Number: 16470767
• Product Code: DQY
• UDI-Device Identifier: 00613994833877
• UDI-Public: 00613994833877
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K022764
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/18/2020

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: 06/23/2021
• Device Model Number: LA7AL10
• Device Catalogue Number: LA7AL10
• Device Lot Number: 0009799944
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1