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

Model Number	LA6AR20SH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician was using a resolute integrity device and a launcher guide catheter to treat a lesion in the mid right coronary artery (rca).The lesion was moderately tortuous and moderately calcified with 80% stenosis.There were no abnormalities reported in relation to the patient¿s anatomy.No issues were noted to the device¿s packaging, no issues were noted when removing the resolute integrity from the hoop/tray.The resolute integrity device was inspected with no issues.The launcher device was not inspected.The launcher device was removed from the packaging and prepped per the ifu.Negative prep was performed on the resolute integrity device with no issues noted.The lesion was pre-dilated, the device did not pass through a previously deployed stent.Resistance was not encountered however excessive force was used.It was stated that the launcher was excessively torqued.It was reported that the launcher became twisted when turning the right subclavian artery and as the resolute integrity device was inside the launcher it also became deformed/twisted at the catheter/delivery system.It was reported that the physician thinks that the event was due to the use of the device¿s in difficult lesion anatomy.The patient is reported to be alive with no injury.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• 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: 8611670
• Report Number: 1220452-2019-00058
• Device Sequence Number: 11268153
• Product Code: DQY
• UDI-Device Identifier: 00613994819772
• UDI-Public: 00613994819772
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: 02/15/2020
• Device Model Number: LA6AR20SH
• Device Catalogue Number: LA6AR20SH
• Device Lot Number: 0008997847
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 07/23/2019
• Initial Report FDA Received Date: 05/15/2019
• Supplement Report FDA Received Date: 08/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 110