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

Model Number	LA6SAL10SH
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher guide catheter was used during a procedure to treat a non-calcified, non-tortuous lesion in the mid right coronary artery (rca).There was no damage noted to the packaging.The device was removed from packaging per ifu with no issues.The device was inspected with no issues.The device was prepped per ifu with no issues.Resistance was not encountered.Excessive force was not used.It was reported that there was sharp corner noted on the tip of the device.After the sharp corner was noted, the physician shaped the tip into a cylindrical shape.The patient is alive with no injury.
Additional Manufacturer Narrative
Product analysis #251944595: one 6f launcher guide catheter was received for analysis.A kink was noted at the proximal end of the shaft approx.3.5cm from the strain relief.No sharp edges or corners were noted on the distal tip.The tip shape appeared deformed.No other deformation was noted.The od of the device measured 0.083¿ meeting specification of 0.082¿ +/- 0.001¿.The id measured 0.071¿ meeting specification of 0.071¿ +/- 0.001¿.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: 9797341
• Report Number: 1220452-2020-00033
• Device Sequence Number: 18979171
• Product Code: DQY
• UDI-Device Identifier: 00613994819499
• UDI-Public: 00613994819499
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2020

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: 09/03/2021
• Device Model Number: LA6SAL10SH
• Device Catalogue Number: LA6SAL10SH
• Device Lot Number: 0009905954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/20/2020
• Initial Date Received by Manufacturer: 03/05/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 03/06/2020
• Supplement Report FDA Received Date: 03/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR