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

Catalog Number	LA6EBU35
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2019
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
A launcher 6f guide catheter was attempted to be used to treat a non tortuous, non calcified lesion in the left main (lm) coronary artery.There was no damage noted to packaging.The device was removed from the packaging as per ifu with no issues.The device was inspected and prepped as per ifu with no issues.Resistance was encountered when advancing the device.It was reported that the device kinked in the middle while in the patient.An image of the device received showed that the device was torsionally kinked.The patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis: a torsional kink was noted on the shaft approx.23cm distal to the strain relief.No other deformation was noted to the device.Still image review: a still image was received in which a torsional kink can be seen on the shaft of a catheter.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: 8703008
• Report Number: 1220452-2019-00076
• Device Sequence Number: 19351180
• Product Code: DQY
• UDI-Device Identifier: 00613994819994
• UDI-Public: 00613994819994
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K021256
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2019

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: 10/30/2020
• Device Catalogue Number: LA6EBU35
• Device Lot Number: 0009413973
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Initial Date Received by Manufacturer: 06/07/2019
• Supplement Date Received by Manufacturer: 07/19/2019
• Initial Report FDA Received Date: 06/17/2019
• Supplement Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 66 YR