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

Catalog Number	LA6EBU35
Health Effect - Clinical Codes	Intimal Dissection (1333); Vascular Dissection (3160)
Date of Event	06/05/2018
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 index procedure one resolute onyx des was implanted in the 1st obtuse marginal and a launcher guide catheter was used, which caused a dissection.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The dissection was a grade d dissection.The dissection was treated with implantation of one resolute onyx stent and medication.The investigator assessed the event as not related to the index device or anti-platelet medication.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: sponsor assessed event is not related to device or anti-platelet medication.Medtronic device caused the dissection.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Correction: correction to medtronic aware date.Previous report was a not late report.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The patient recovered.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: 7721537
• Report Number: 1220452-2018-00094
• Device Sequence Number: 1050816
• Product Code: DQY
• UDI-Device Identifier: 00613994819994
• UDI-Public: 00613994819994
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 09/18/2019

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: 03/25/2020
• Device Catalogue Number: LA6EBU35
• Device Lot Number: 0009044972
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/27/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 11/06/2018; 07/02/2019; 07/02/2019; 08/21/2019
• Initial Report FDA Received Date: 07/26/2018
• Supplement Report FDA Received Date: 10/02/2018; 11/12/2018; 07/10/2019; 09/12/2019; 09/18/2019
• 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: 76 YR
• Patient Weight: 86