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

Model Number	LA6AR10
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: one 6fr launcher guide catheter was received for analysis.Kinks were noted on the shaft of the catheter approx.7.4cm, 44.6cm and 80.5cm, distal to the strain relief.A torsional kink was noted on the shaft of the catheter approx.29cm distal to the strain relief.No damage was noted to the distal tip.The id of the catheter measured within specification.The shaft od measured within specification.It was not possible to load a 0.035 inch guidewire through the lumen due to the deformation on the catheter.No other damage was noted to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure, an attempt was made to use one 6 french launcher guide catheter to treat a lesion.A femoral procedural approach was used.There was no damage evident to the protective packaging of the device.There was no resistance noted while removing the device from packaging.The device was inspected after removal from packaging.The device was not excessively torqued.There was no resistance noted during the insertion/delivery of the device.It was reported that multiple kinks in proximal, mid and distal portions of the guide occurred while in the patient.It was stated that the kinks were observed as the tip was being advanced into the sheath.The guide catheter was removed immediately from the body.It was stated that the guide was not advanced past the aortic arch.The patient was reported to be alive with no injury.

• 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: 12015069
• Report Number: 1220452-2021-00023
• Device Sequence Number: 3403841
• Product Code: DQY
• UDI-Device Identifier: 00613994820433
• UDI-Public: 00613994820433
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K132673
• 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): 06/17/2021

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: 12/03/2021
• Device Model Number: LA6AR10
• Device Catalogue Number: LA6AR10
• Device Lot Number: 0010043858
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2021
• Initial Report FDA Received Date: 06/17/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1