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

Model Number	LA6JL35
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation summary: received for analysis was one 6fr launcher guide catheter.A torsional kink was noted on the shaft of the catheter, approx.9.6cm distal to the strain relief.The wire braid was exposed at the location of the torsional kink.The catheter id and od measurements were within specification.No damage was noted to the distal tip.No damage was noted to the remainder of the device.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
During a procedure, two 6 french launcher guide catheters were intended to be used.There was no damage noted to the packaging.The devices were removed from packaging and prepped per ifu with no issues noted.The devices were inspected with no issues noted.Excessive force was not used during insertion.Resistance was not noted when advancing the second guide catheter (lot#: 0010259138).It was reported that both guide catheters were kinked.It was stated that the kink was noted on the first guide catheter (lot#: 0009935514) during insertion of the device into the patient.It was stated that the second guide catheter (lot#: 0010259138) was noted to be kinked before use in the patient.It was indicated that one kink was proximal and the other was distal.The procedure was completed using another launcher guide catheter.No patient injury was reported.
Additional Manufacturer Narrative
Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.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: 11011246
• Report Number: 1220452-2020-00099
• Device Sequence Number: 19786557
• Product Code: DQY
• UDI-Device Identifier: 00613994818157
• UDI-Public: 00613994818157
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/16/2020

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: 09/23/2021
• Device Model Number: LA6JL35
• Device Catalogue Number: LA6JL35
• Device Lot Number: 0009935514
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2020
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 12/15/2020
• Initial Report FDA Received Date: 12/15/2020
• Supplement Report FDA Received Date: 12/16/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1