MAUDE Adverse Event Report: MEDTRONIC, INC SITESEER 4F DIAGNOSTIC CATHETER; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Catalog Number	4A0029
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Patient Problem/Medical Problem (2688)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The physician used a siteseer catheter during the procedure.There was no damage noted to the siteseer catheter packaging.The catheter was removed from the packaging per ifu with no issues.The catheter was inspected and prepped per ifu with no issues.The device was used in the aorta, which was non-tortuous and non- calcified.There were no abnormalities reported in relation to anatomy.The procedure involved a right heart case, and a non-medtronic wire was used.Resistance was encountered during delivery to the target lesion, with the non-mdt guidewire inserted through the lumen of the siteseer catheter.Resistance was felt manoeuvring the catheter in vivo, and the catheter kinked.Excessive force was not used.It is reported that in the holding room when the physician removed the catheter from the patient, they found part of the catheter was broken.The tip of the siteseer was found in the introducer sheath.The sheath was cut open by the physician to remove the detached tip of the siteseer catheter.There was no resistance noted when removing the non-medtronic wire from the catheter.The catheter was not excessively torqued.The procedure was not completed due to the event.
Additional Manufacturer Narrative
Product analysis summary: the distal tip segment is separated at the distal bond joint proximal to the side holes.The detached distal segment shows stretching at the proximal side hole.It also appears that material is protruding outward in a distal direction from the side hole.The distal tip of the catheter is torn or cut.The siteseer catheter shaft is kinked 4cm from the strain relief.If information is provided in the future, a supplemental report will be issued.

• Brand Name: SITESEER 4F DIAGNOSTIC CATHETER
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• MDR Report Key: 7057278
• Report Number: 1220452-2017-00119
• Device Sequence Number: 155884
• Product Code: DQO
• UDI-Device Identifier: 20613994894452
• UDI-Public: 20613994894452
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K984627
• 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): 03/28/2018

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: 11/02/2018
• Device Catalogue Number: 4A0029
• Device Lot Number: 50945006
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2017
• Initial Date Received by Manufacturer: 10/26/2017
• Supplement Date Received by Manufacturer: 02/27/2018
• Initial Report FDA Received Date: 11/23/2017
• Supplement Report FDA Received Date: 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1