MAUDE Adverse Event Report: MEDTRONIC, INC SITESEER DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	4A0025
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	12/17/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Product analysis summary: received for analysis was one 4f siteseer diagnostic catheter coil wrapped with original packaging.As received, the distal segment of the catheter is detached and not received.The pigtail straightener still no the proximal shaft of the catheter.The detachment is at the distal segment bond joint.Approximately 8cm of the distal end of the catheter is missing.The jagged edge at the break indicates the catheter segment and shaft did go through the bonding process in manufacturing.Image review: a review of the case cine (series 8 frame 3/10) shows what appears to be a 3" portion of the catheter in the right radial artery at the elbow.This is consistent with what is missing from the returned catheter.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
A siteseer catheter was intended to be used to treat a non-calcified lesion in the aorta.The device was intended to reach the aorta to the valve.There was no damage noted to the device packaging.Device removed from packaging per ifu with no issues.Device was not inspected.Device was prepped with no issues.Resistance was experienced during use, during delivery to the target lesion.Excessive force was not used during insertion/delivery.It is reported that the device could not cross the elbow, so the physician tried to pull it back.The tip of the device then detached in the forearm, and remained in the radial artery.The device was not excessively torqued.The patient was then put in surgery.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: SITESEER DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 8226112
• Report Number: 1220452-2019-00004
• Device Sequence Number: 2070127
• Product Code: DQO
• UDI-Device Identifier: 00613994851161
• UDI-Public: 00613994851161
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K984627
• 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,Followup
• Report Date (Section B): 04/09/2019

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: 03/14/2020
• Device Catalogue Number: 4A0025
• Device Lot Number: 51024822
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Initial Date Received by Manufacturer: 12/19/2018
• Supplement Date Received by Manufacturer: 04/08/2019
• Initial Report FDA Received Date: 01/08/2019
• Supplement Report FDA Received Date: 04/09/2019
• 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
• Patient Age: 42 YR
• Patient Weight: 85