MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 7F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Model Number	LA7AL10
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis:one 7f launcher guide catheter was returned for analysis.Torsional kinks were noted on the proximal shaft approx.32-33cm and 35cm from the strain relief.Wire braid was exposed at both kink sites.The od of the device measured 0.094¿ meeting specification of 0.094¿ +/- 0.001¿.The id measured 0.081¿ meeting specification of 0.081¿ +/- 0.001¿.No other deformation noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
One launcher guide catheter was attempted to be used.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.It was reported that the catheter kinked while in the patient.The patient was reported to be alive with no injury.

• Brand Name: LAUNCHER 7F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 10331041
• Report Number: 1220452-2020-00069
• Device Sequence Number: 951629
• Product Code: DQY
• UDI-Device Identifier: 00613994833877
• UDI-Public: 00613994833877
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K022764
• 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
• Report Date (Section B): 07/28/2020

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: 07/14/2021
• Device Model Number: LA7AL10
• Device Lot Number: 0009830576
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2020
• Initial Report FDA Received Date: 07/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1