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

Model Number	LA6EBU375
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/05/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis: received for analysis was a 6f launcher guide catheter, preloaded into a non-mdt introducer sheath.A non-mdt y-connector was connected to the catheter hub.A non-mdt angiographic wire was preloaded into the y-connector and into the catheter shaft.The y-connector disconnected from the catheter hub with no issues.No deformation noted to the y-connector.The angiographic wire was removed from the catheter with resistance noted.Based on the shape of the distal tip of the wire, it appears the wire got stuck in a site of deformation in the catheter shaft.The wire od was confirmed as 0.035¿.The returned wire was loaded into the catheter shaft and stopped at a site of deformation in the shaft and would not advance further.Slight torsional kinks were noted on the catheter shaft approx.30-33.5cm from the strain relief.Exposed wire braid was noted at the deformation site.A torsionally kinked section on the catheter was noted approx.41-47cm from the strain relief.Exposed braid was also seen at this deformation site.A kink was noted approx.48cm from the strain relief.The id of the catheter measured 0.071¿ meeting specification of 0.071¿ +/- 0.001¿.The shaft od measured 0.082¿ meeting specification of 0.082¿ +/- 0.001¿.The catheter length measured approx.100cm, indicating the catheter had not been stretched.No crack was noted in the catheter.No other deformation noted to the catheter shaft.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher guide catheter was intended to be used during a procedure.No damage was noted to packaging.The device was removed from packaging per ifu.The device was inspected and prepped per ifu with no issues noted.It was reported that the launcher stretched and changed shape during the procedure.The device was damaged during intubation attempt of left coronary artery.There was no obvious anatomical problem.No significant force was used to rotate the catheter.A crack was noted followed by rotation problems.Attempt of reintroducing the guidewire failed.Fluoro showed the broken catheter low at the level of the distal abdominal aorta.Attempt to rotate and straighten the broken part failed as well.Retraction to femoral sheath and attempt to remove the device through it failed.To avoid losing the distal part of catheter with extensive force applied, the launcher device with the sheath were removed all together and it was successful.Patient required protamine sulphate infusion and prolonged manual compression of puncture site.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: 9749526
• Report Number: 1220452-2020-00028
• Device Sequence Number: 740879
• Product Code: DQY
• UDI-Device Identifier: 00613994821348
• UDI-Public: 00613994821348
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• 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): 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/04/2021
• Device Model Number: LA6EBU375
• Device Catalogue Number: LA6EBU375
• Device Lot Number: 0010046568
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/25/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR