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

Catalog Number	LA6JR40
Medical Device Problem Codes	Leak/Splash (1354); Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	Air Embolism (1697)
Date of Event	07/26/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher device was attempted to be used during a procedure to treat a severely tortuous, severely calcified lesion exhibiting 70% stenosis in the ostium of the right coronary artery (rca).There was no damage noted to the 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.It was reported that the subclavian was extremely tortuous and caused the guide catheter to severely kink after post dilation.It was also reported that there was a small hole where the guide kinked which caused an air emboli.The air emboli resulted in st elevation with slow flow, which was then treated with nipride.No further patient injury was reported.
Additional Manufacturer Narrative
It was stated that the device was excessively torqued because of the tortuous anatomy of the sub clavian.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
One 6f launcher guide catheter was received for analysis.A torsional kink was evident on the proximal end of the shaft approx.7.5cm from the strain relief.Exposed wire braid was evident on both sides of the kink.Small holes were noted where the wire braid was exposed.The catheter was flushed with water and leaked out of these small holes.No other deformation was noted on the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: the lesion was pre-dilated, stented and post-dilated without complication.An attempt was being made to manipulate the device in a normal fashion to maintain access but during the manipulation the guide catheter was thought to have kinked.During post angiogram of the right coronary artery bubbles were sent down the vessel.The patient was started on a levophed drip.No further patient injury was reported.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: 8840203
• Report Number: 1220452-2019-00092
• Device Sequence Number: 13518610
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: 00613994817778
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Initial Reporter Country: US
• 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,Followup,Followup
• Report Date (Section B): 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/02/2021
• Device Catalogue Number: LA6JR40
• Device Lot Number: 0009768419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 07/26/2019
• Supplement Date Received by Manufacturer: 07/30/2019; 08/27/2019; 11/06/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/22/2019; 09/25/2019; 11/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 85 YR
• Patient Weight: 77