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

Model Number	LA6JR40
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: one 6f launcher guide catheter was received for analysis.A non-mdt mating device was attached to the hub of the catheter and a non-mdt introducer sheath was attached to the shaft.No damage was noted to the returned introducer sheath however during analysis the introducer was cut open to facilitate the removal of the guide catheter.No damage was noted to the returned mating device.During analysis, a detachment of the shaft occurred approx.55cm from the distal tip.The ends of the detached portions of the catheter appeared slightly jagged.A severely torsionally kinked section was noted towards the proximal end of the shaft, approx.36-38cm from the strain relief, followed by a flattened section on the catheter.Exposed wire was evident.No damage was noted to the distal end of the catheter.The od of the catheter measured 0.082¿ meeting specification of 0.082 +/- 0.001¿.The id of catheter measured 0.071¿ meeting specification of 0.071¿+/- 0.001¿.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher 6f guide catheter was used to treat a mildly tortuous lesion with 99% stenosis in the mid rca.There was no damage noted to the device packaging.The device was removed from the packaging and prepped as per ifu.The device was inspected prior to use.Resistance was not encountered when advancing the device and excessive force was not used during delivery.The device was not excessively torqued.It was reported that the distal end of the guide catheter kinked while the device was in the iliac, just past the sheath.The patient is alive with no injury.

• 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: 9408540
• Report Number: 1220452-2019-00154
• Device Sequence Number: 4202109
• Product Code: DQY
• UDI-Device Identifier: 00613994817778
• UDI-Public: 00613994817778
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K132673
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: 04/15/2021
• Device Model Number: LA6JR40
• Device Catalogue Number: LA6JR40
• Device Lot Number: 0009693594
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2019
• Initial Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 98