MAUDE Adverse Event Report: MEDTRONIC, INC LAUNCHER 5F GUIDE CATHETER; CATHETER, PERCUTANEOUS

Catalog Number	LA5JR40
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	08/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Received for analysis was one 5f launcher guide catheter.Deformation was noted approx.27.5cm-30cm from the strain relief.A torsional kink was evident on the catheter.The shaft appeared crushed and several kinks were noted.Wire braid was visible.The shaft od measured 0.068¿ meeting specification of 0.068¿ +/- 0.001¿.The id of the device met specification of 0.058¿ +/- 0.001¿.No other deformation was noted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A launcher 5f guide catheter was used to treat a moderately tortuous, moderately calcified lesion in the right coronary artery (rca).There was no damage noted to packaging.The device was removed from packaging as per ifu with no issues.The device was inspected with no issues.The device was prepped as per ifu with no issues.Resistance was encountered when advancing the device.Excessive force was not used during delivery.The device was not excessively torqued.It was reported that resistance was experience during delivery to the target lesion and the catheter buckled in the middle of the catheter as they tried to engage.It was also reported that after some struggle the catheter was extracted from the sheath and once the sheath was removed hematoma was noticed.No intervention was required to remove the device from the sheath.

• Brand Name: LAUNCHER 5F GUIDE CATHETER
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 9212731
• Report Number: 1220452-2019-00137
• Device Sequence Number: 2589236
• Product Code: DQY
• UDI-Device Identifier: 00613994782687
• UDI-Public: 00613994782687
• Combination Product (Y/N): N
• Initial Reporter State: ID
• 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): 10/21/2019

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: 04/17/2021
• Device Catalogue Number: LA5JR40
• Device Lot Number: 0009693798
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2019
• Initial Report FDA Received Date: 10/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 72 YR
• Patient Weight: 104