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

Catalog Number	LA6JR40
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/17/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the physician used a launcher la6jr40 guide catheter (gc) when treating a lesion exhibiting moderate tortuosity and moderate calcification, located in the ostium of the rca.There were no abnormalities reported in relation to anatomy.There was no damage noted to packaging.The device was removed from packaging, inspected and prepped as per the ifu with no issues.Resistance was encountered when advancing the device.The physician noted that the resistance was due to interaction with another device.Excessive force was not used during insertion/delivery.It was noted that during the pci procedure, the physician observed that the guiding catheter looked abnormal.The device was removed from the patient, and the steel wire braid of the device was found fractured.No report of the device being torqued at any stage during the procedure.The physician replaced the device with a new mdt catheter to complete the operation.There is no patient injury reported.
Additional Manufacturer Narrative
Product analysis summary: the inner (id) and outer (od) diameters of the shaft meet specification.The catheter tip is round, smooth and undamaged.The catheter was torsionally kinked 36cm from the proximal strain relief.The torsional kink appears to be approximately 6 turns on the catheter.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: 6954255
• Report Number: 1220452-2017-00102
• Device Sequence Number: 683147
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: 00613994817778
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/14/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/05/2018
• Device Catalogue Number: LA6JR40
• Device Lot Number: 0007882674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2017
• Initial Date Received by Manufacturer: 09/18/2017
• Supplement Date Received by Manufacturer: 11/17/2017
• Initial Report FDA Received Date: 10/17/2017
• Supplement Report FDA Received Date: 12/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1