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

Catalog Number	LA7AL75
Medical Device Problem Codes	Material Distortion (2977); Material Torqued (2980)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/10/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a 7f launcher guide catheter to treat a moderately tortuous, moderately calcified lesion in the proximal-mid rca.The patient had peripheral artery disease (pad) and an occluded superficial femoral artery (sfa).There was no damage noted to 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 when advancing the device.Excessive force was used and the device was excessively torqued.It is reported that the proximal end of the catheter kinked while in the patient.The iliac artery was dissected as a result.Pressure was applied to the groin site and a long sheath was left in place and sewn in at the access site for tamponade.No breakage of the device occurred.No portion of the device detached.It is reported that a device malfunction is not suspected - rather that the issue was a result of excessive torque.
Additional Manufacturer Narrative
Product analysis: the device was returned for analysis and as received the catheter was coil wrapped with the original pouch label.A torsional kink/twist was evident on the catheter shaft.The outer jacket material is fractured and there is exposed braid wire.The shaft meets specification.No other damage was noted to the device.If information is provided in the future, a supplemental report will be issued.

• 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: 7003391
• Report Number: 1220452-2017-00112
• Device Sequence Number: 1299462
• Product Code: DQY
• UDI-Device Identifier: 00613994834065
• UDI-Public: 00613994834065
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K022764
• 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,Followup
• Report Date (Section B): 12/15/2017

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: 07/26/2018
• Device Catalogue Number: LA7AL75
• Device Lot Number: 0008156725
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2017
• Initial Date Received by Manufacturer: 10/10/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 12/15/2017
• 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: Required Intervention