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

Catalog Number	LA7EBU35
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: a torsional kink was noted 25cm from the proximal hub.No other damage was noted to the catheter.Actual physical measurements id 0.081¿ and od 0.0942¿ passing measurements per specifications.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A 7f launcher guide catheter was used in a procedure to treat a lesion in the lad.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.Mild resistance was encountered when advancing the device.Excessive force was not used during delivery.It is reported that the catheter kinked while advancing in the artery.No patient injury is reported.The procedure was completed using another 7f launcher device.Analysis of the returned device revealed a torsional kink on the device, 25cm from the proximal hub.

• 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: 8264089
• Report Number: 1220452-2019-00007
• Device Sequence Number: 16566899
• Product Code: DQY
• UDI-Device Identifier: 00613994834713
• UDI-Public: 00613994834713
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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): 01/21/2019

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: 05/01/2020
• Device Catalogue Number: LA7EBU35
• Device Lot Number: 0009123581
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2019
• Initial Report FDA Received Date: 01/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR