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

Catalog Number	LA6MAC3030
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: the catheter exhibited a severely torsional kinked 51 cm from the distal tip.The outer jacket of the shaft showed exposed braid due the severe kink.The tip of the catheter was round and smooth.No other damage noted to the catheter.Dried thrombus and the torsional kink prevented from flushing the catheter with water or passing an in-house wire thru the lumen.Due to the damage to the catheter further testing could not be completed.Actual inner and outer diameter met specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher guide catheter was attempted to be used.A radial approach was used.The device was removed from the packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.Resistance was encountered when advancing the device.Excessive force was not used.It is reported that a 0.014 x 180 wire was unable to be passed through the catheter and upon removal the proximal portion of the catheter was noted to be severely kinked.No patient injury is reported.

• 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: 7872131
• Report Number: 1220452-2018-00109
• Device Sequence Number: 228459
• Product Code: DQY
• UDI-Device Identifier: 00613994818089
• UDI-Public: 00613994818089
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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
• Report Date (Section B): 09/13/2018

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: 10/04/2019
• Device Catalogue Number: LA6MAC3030
• Device Lot Number: 0008822887
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/12/2018
• Initial Report FDA Received Date: 09/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR