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

Catalog Number	LA6JR40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	08/20/2019
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, a launcher guide catheter was used to treat a mildly calcified, moderately tortuous mid distal lesion exhibiting 85% stenosis and a proximal lesion exhibiting 60% stenosis in the ostium of the right coronary artery (rca).The lesion was pre-dilated.It was reported that a dissection occurred from the ostium to mid/distal rca.The dissection was caused by the launcher guide catheter.Four resolute onyx rx coronary, drug eluting stents (ronyx22538x, ronyx35038x, ronyx35038x, ronyx35022x) were used to treat the dissection.The devices were inspected with no issues.Negative prep was performed with no issues.The devices did pass through a previously deployed stent.Resistance was not encountered when advancing the devices and excessive force was not used during delivery of the devices.The stent balloon was used to pre-dilate the overlap of stents.It was reported that it was difficult to remove the stent delivery systems of the two 3.50x38 mm devices from a non-medtronic wire following post-dilation.The same wire had been used throughout the case.It was reported that a good result was achieved from using the four resolute onyx stents to treat the dissection.
Additional Manufacturer Narrative
Product analysis: one 6f launcher guide catheter was received for analysis.A kink was evident beside the strain relief at the proximal end of the catheter.No other deformation was noted on the device.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: 8968626
• Report Number: 1220452-2019-00110
• Device Sequence Number: 11284775
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: 00613994817778
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K021256
• 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
• Report Date (Section B): 11/06/2019

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: 06/19/2021
• Device Catalogue Number: LA6JR40
• Device Lot Number: 0009795984
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2019
• Initial Date Received by Manufacturer: 08/20/2019
• Supplement Date Received by Manufacturer: 10/16/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 11/06/2019
• 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: 50 YR