MAUDE Adverse Event Report: UNK, EITHER MEDTRONIC OR EDWARDS LIFESCIENCE FEMORAL ARTERIAL CANNUL; CANNULA, ARTERIAL

Device Problems Device Dislodged or Dislocated (2923); Device Handling Problem (3265)

Patient Problems Cardiac Arrest (1762); Cardiomyopathy (1764); Renal Failure (2041)

Event Date 02/04/2014

Event Type  Injury  

Event Description

On (b)(6) 2014, (b)(4) of the cardiac assist clinical support staff was contacted by the hospital staff of (b)(6) hospital.The charge nurse said that the th 'somehow came out' and they were coding the pt and trying to 'put it back in'.The site reported that the arterial cannula came out all the way.The cannula was a competitor's cannula (not designed or manufactured by cai).(b)(4) advised the site that they could have a venous and arterial cannula placed at the bed side with perfusion adding an oxygenator but anything else would require the pt going back to the lab.The charge nurse requested a sales rep to come on site however there was no sales rep in the area at the time of the event.On (b)(6) 2014, (b)(4) was informed that the arterial cannula was switched out and the pt has been resuscitated.Th 4.4 1pm at 7500, big guy approx 300#.Hr 126, 86/75 (79), cvp 22 despite massive diuresis.On (b)(6) 2014, further detail was obtained as follows "the nurse at the bedside told me about the arterial cannula dislodgement last week.She said the nurse had changed the pts dressing and the cannula was 'fine', a bit later, she stepped away to retrieve meds and the ct fellow came to the bedside and removed the dressing and the arterial cannula came out with it.Hemostasis was somehow achieved at the bedside while another cannula was placed in the rfa.

Manufacturer Narrative

Event reported due to similarity with cai product, although cai product has add'l design features for safety that mitigate this particular hazard.

• Brand Name: FEMORAL ARTERIAL CANNUL
• Type of Device: CANNULA, ARTERIAL
• Manufacturer (Section D): UNK, EITHER MEDTRONIC OR EDWARDS LIFESCIENCE
• Manufacturer Contact: kevin posey ; 240 alpha drive; pittsburgh, PA 15238 ; 4129637770
• MDR Report Key: 3672160
• MDR Text Key: 4339398
• Report Number: 2531527-2014-00003
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120543
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2014

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?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2014
• Initial Date FDA Received: 02/24/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 136