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

Catalog Number	LA6JR35
Medical Device Problem Codes	Component or Accessory Incompatibility (2897); Material Distortion (2977)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); Vascular Dissection (3160)
Date of Event	01/03/2018
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
The physician intended to use a 6f launcher guide catheter.There was no damage noted to the device packaging.The device was removed from the packaging per ifu.The device was inspected with no issues.The device was prepped per ifu with no issues.The device was not excessively torqued.The proximal right radial artery was the access site.The artery was non-tortuous and non-calcified.No resistance was noted when inserting the introducer.Resistance was experienced when inserting the catheter through the 6f non-mdt introducer, with another device inserted through the lumen of the guide catheter.The catheter was used on a teflon guidewire and a unidirectional valve.It is reported that at the moment of the transition from the introducer to the catheter the physician felt resistance of the proximal radial artery.Excessive force was not used during delivery.The physician tried once to rotate the launcher device to see if it would move better, but it did not work and dissection of the proximal third of the forearm occurred.The catheter was removed and it was noted that the tip was deformed- the tip was irregular.No portion of the catheter was detached.To treat the dissection, the introducer was removed and a local compression of the site was done.No additional intervention was required.The physician then changed the access point and the procedure was completed without complication.No further patient injury is reported.
Additional Manufacturer Narrative
Product analysis summary; the catheter exhibited blood stains.As received the catheter was wavy.Closer visual inspection detected a crushed section on the shaft 25cm from the hub.During close inspection of the tip, white material damage was noted to the tip.The damage consisted of folding inward of the tip.During analysis the catheter was decontaminated, and visual inspection was conducted resulting in no noticeable damage.Actual physical measurements of the outer diameter and inner lumen met specification.The tip exposed length was also within specification.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: 7232309
• Report Number: 1220452-2018-00010
• Device Sequence Number: 1174170
• Product Code: DQY
• UDI-Device Identifier: 00613994817723
• UDI-Public: 00613994817723
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 05/16/2018

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: 06/07/2019
• Device Catalogue Number: LA6JR35
• Device Lot Number: 0008668184
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2018
• Initial Date Received by Manufacturer: 01/03/2018
• Supplement Date Received by Manufacturer: 04/24/2018
• Initial Report FDA Received Date: 01/31/2018
• Supplement Report FDA Received Date: 05/16/2018
• 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: 49 YR
• Patient Weight: 76