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

Catalog Number	LA6ERADR
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/06/2019
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
During a procedure, an attempt was made to use a 6f launcher guide catheter to do a diagnostic on the rca.No damage was noted to pac kaging.The device was removed from the packaging as per ifu with no issues.The device was inspected with no issues noted.Resistance was not encountered when advancing the device and excessive force was not used during insertion.Multiple curves were used to try to cannulate the rca.The launcher was used as no other catheters worked.It was reported that when the catheter was injected for a root shot, an aortic perforation was noticed in the sub intimal tissue of the right cusp.The patient was stable and no surgery was required that day to repair the perforation.Patient was discharged the following day.
Additional Manufacturer Narrative
Image analysis: one still image showing what appears to be blush from contrast in the vasculature was provided.A photo of the device packaging with product identification details was also provided.The still image confirms the presence of contrast where the reported perforation appears to have occurred.It provides no insight into the root cause or the resolution of the issue.There is no identified device failure or root cause from this image provided.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The lesion was non-tortuous and had very minimal calcification.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: 8644151
• Report Number: 1220452-2019-00070
• Device Sequence Number: 3019971
• Product Code: DQY
• UDI-Device Identifier: 00613994821508
• UDI-Public: 00613994821508
• 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
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/19/2019

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 11/25/2020
• Device Catalogue Number: LA6ERADR
• Device Lot Number: 0009458666
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/20/2019
• Supplement Date Received by Manufacturer: 06/07/2019; 08/22/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 07/04/2019; 09/19/2019
• 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: Other
• Patient Age: 64 YR
• Patient Weight: 94