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

Catalog Number	LA6AL10
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	02/01/2019
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 intended to be used during a procedure.No damage noted to packaging.No issues when removing the device from the packaging as per ifu.The device was inspected and prepped as per ifu with no issues.It is reported that the device broke off while in the aorta.No resistance was encountered when advancing the device, no excessive force was used during delivery.It is reported that the patient has been moved for surgery to remove the catheter.No further patient injury reported.
Additional Manufacturer Narrative
Add info: the device was being used in a procedure to treat an anomalous rca.Multiple catheters were attempted with no success.The physician had no issues using the catheter in the patient but when they started to pull the catheter it looked to be kinked and then it broke about quarter way down the catheter.The remainder of the catheter was successfully removed through the femoral artery.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Product analysis: one launcher catheter 6f 100cm al10 was received for analysis.Only the proximal 40cm of the catheter was returned.There is a kink 14cm from the strain relief and the break exhibits twisting to break.The distal end of the catheter reportedly removed from the patient was not returned for analysis.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: 8301251
• Report Number: 1220452-2019-00011
• Device Sequence Number: 13865489
• Product Code: DQY
• UDI-Device Identifier: 00613994820327
• UDI-Public: 00613994820327
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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
• Report Date (Section B): 06/06/2019

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: 04/03/2019
• Device Catalogue Number: LA6AL10
• Device Lot Number: 0008563972
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2019
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 02/04/2019; 05/07/2019
• Initial Report FDA Received Date: 02/04/2019
• Supplement Report FDA Received Date: 03/05/2019; 06/06/2019
• 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