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

Catalog Number	LA6EBU35
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Image analysis: a still image was received in which the distal segment of a launcher device is shown.A kink can be seen on the primary curve which closely resembles what was seen on the returned device.Product analysis: device returned in a plastic bag.Lot number on mpxr report 0009589008 as reported.Kinking/flattening was noted to the shaft approx.43-45cm distal to the strain relief.The deformation occurred on opposing planes.A torsional kink was noted on the distal segment, with inner material slightly exposed at the kink site.Slight deformation was noted to the distal tip, with the material forming an oval-shape.It was possible to verify the id with a 0.071¿ pin gauge.No other deformation was noted to the device.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 to treat a non calcified, moderately tortuous left anterior descending (lad) artery.There was no damage noted to the packaging.The device was removed from packaging as per ifu with no issues.The device was inspected with no issues noted.The device was prepped per ifu.Resistance was encountered when advancing the device.It was indicated that the device may have been excessively torqued.It was reported that the device kinked at the distal end when removing the device from the patient.The patient is alive with no injury.At the facility devices are removed from the outer box and hung up.The cath lab will not be reviewed as it was stated that launchers have a hanging rack and are in an open space.The device was returned with a torsional kink and the inner material slightly exposed at the kink site.

• 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: 9075254
• Report Number: 1220452-2019-00127
• Device Sequence Number: 2477991
• Product Code: DQY
• UDI-Device Identifier: 00613994819994
• UDI-Public: 00613994819994
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/17/2019

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: 02/11/2021
• Device Catalogue Number: LA6EBU35
• Device Lot Number: 0009589008
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 77 YR