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

Model Number 4A0061

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Patient Problem/Medical Problem (2688); Device Embedded In Tissue or Plaque (3165)

Event Date 04/25/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

The physician was attempting to use a siteseer pigtail diagnostic catheter during a procedure to treat a lesion in the aorta.The device was removed from packaging, inspected and prepped with no issues noted.The device appeared normal.Resistance was not noted during delivery or withdrawal of the device to/from the lesion site.During injection of the aorta aortogram, to evaluate an aneurysm in the descending aorta, a fragment of the catheter became detached, the tip was found in the patient under ct, but was not retrieved.Patient health status post procedure is described as alive, with no injury.

Manufacturer Narrative

Evaluation summary: the device was returned to the manufacturing for evaluation.The catheter is missing the distal segment approximately 7cm in length.The segment with 6 side holes reportedly remains in the patient.Usable length from end of strain relief to break measures 101.6cm.The id measures.042¿.There is no visible physical damage to the shaft at the break site that would indicate kink or crush contributed to the detachment.Sem inspection of catheter: the catheter was evaluated via sem.The failed unit was evaluated and compared to a known-good sample (the sample was pulled apart via tensile test method and confirmed to be meeting specification).There is a visual similarity between the proximal segment of the test sample and that of the proximal portion from the complaint device, with respect to both having the characteristic ¿disrupted surface¿.On more rigorous inspection it can be seen how the outer layers of both segments were stretched with considerably necking on the softer more compliant distal portion.The ¿disrupted surfaces¿ on the proximal and the distal segments look very similar which indicate that this surface effect can be created by stretching which suggests a tensile failure mode.The disrupted surface was observed over the 2.39mm length.This suggests that bond created in manufacturing was built correctly.Similarly the necking and stretching observed suggests that the material resisted the tensile force until finally yielding.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: SITESEER 4F DIAGNOSTIC CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer (Section G): MEDTRONIC, INC; 37a cherry hill dr; danvers MA 01923
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; 091708734
• MDR Report Key: 5675429
• MDR Text Key: 45756852
• Report Number: 1220452-2016-00036
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K984627
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 08/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/24/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2018
• Device Model Number: 4A0061
• Device Catalogue Number: 4A0061
• Device Lot Number: 50939373
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/11/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1