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

Catalog Number	LA6JR40
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Material Distortion (2977)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/11/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis summary: as received the catheter is still engaged in the non-medtronic introducer sheath.The guide catheter is kinked, twisted crushed, and cut on the distal side of the introducer sheath distal to the tip of the introducer sheath 63cm from the strain relief.The condition of the returned devices is consistent with the reported event.The distal end of the guide catheter was not returned for analysis.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician intended to use a launcher guide catheter to treat a severely tortuous, moderately calcified lesion with chronic total occlusion in the proximal right coronary artery.There was no damage noted to the device packaging.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.The device was not excessively torqued.Resistance was not encountered when advancing the device and excessive force was not used during insertion/delivery.The common femoral presented with tortuosity and calcium.The 6fr non-mdt sheath angle was very steep and the sheath was kinked during the procedure and locked on to the guide catheter.The physician had to remove the sheath and the launcher at the same time as they were stuck together.Then the guide catheter was still up over the arch.At that time the launcher was cut (outside the patient body) distal to the removed sheath that was locked onto the guide catheter.A 0.035 non-mdt wire was re-introduced through the cut portion of the guide catheter, along where the cut was made, to safely remove it from the patient.The lumen was crushed on the guide so no.035 wire could be re-introduced through the tuohy, guide and sheath.No patient injury is reported.
Additional Manufacturer Narrative
Cine image analysis: the image shows a coronary angiography (cag) of the femoral artery.The image captures the 6fr non-medtronic sheath at what appears to be a very steep angle, together with the launcher guide catheter inserted through the sheath.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: 7174477
• Report Number: 1220452-2018-00001
• Device Sequence Number: 1812784
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: 00613994817778
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K021256
• 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
• Report Date (Section B): 11/07/2018

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2019
• Device Catalogue Number: LA6JR40
• Device Lot Number: 0008848686
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2017
• Initial Date Received by Manufacturer: 12/11/2017
• Supplement Date Received by Manufacturer: 10/10/2018
• Initial Report FDA Received Date: 01/09/2018
• Supplement Report FDA Received Date: 11/07/2018
• 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: 56 YR
• Patient Weight: 107