MAUDE Adverse Event Report: PERFUSION SYSTEMS DLP LEFT ATRIAL PRESSURE MONITORING CATHETER; APPARATUS, AUTOTRANSFUSION

Model Number 50010

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Code Available (3191)

Event Date 05/02/2014

Event Type  Injury  

Event Description

Medtronic received information that a patient underwent orthotropic heart transplant on (b)(6) 2014 for dilated ischemic cardiomyopathy.A left atrial line was placed during the surgery to measure the left atrial pressure.On (b)(6) 2014, during bedside removal of the left atrial line in the intensive care unit (icu) the line broke at the patient's skin level.The event was discovered immediately, and on (b)(6) 2014 the patient was taken to the operating room for exploration and removal of the retained portion of the line.The removal was successful with no patient complications.The product was returned to medtronic for analysis.

Event Description

Medtronic received information that a patient underwent orthotropic heart transplant on (b)(6) 2014 for dilated ischemic cardiomyopathy.A left atrial line was placed during the surgery to measure the left atrial pressure.On (b)(6) 2014, during bedside removal of the left atrial line in the intensive care unit (icu) the line broke at the patient's skin level.The event was discovered immediately, and on (b)(6) 2014 the patient was taken to the operating room for exploration and removal of the retained portion of the line.The removal was successful with no patient complications.The product was returned to medtronic for analysis.

Manufacturer Narrative

Upon receipt at medtronic's quality laboratory, visual inspection confirmed that the catheter had broken off.The portion of the device that was surgically recovered from the patient was not returned for analysis.The catheter has been sent to medtronic's core technologies laboratory for detailed analysis of the point where the material separated.Upon completion of detailed analysis and investigation of the root cause, a supplemental report will be filed.(b)(4).

Manufacturer Narrative

One portion of the event device was returned to medtronic for analysis.Upon receipt, dimensional analysis confirmed that the returned device tubing met the drawing diameter of 0.039 to 0.043 inches.The pvc tubing from the returned device was chemically compared to tubing from a sample product using atr-ir and raman spectroscopy.Both methods of analysis confirmed that the chemical composition of the returned tubing and control tubing were consistent with one another and aligned with expectations for the materials.Visual inspection under magnification showed that the ruptured end of the returned device where the break was reported exhibited rough edges and a separation surface.Pull testing was performed with samples from the catheter lots that were returned to medtronic.After pulling to failure, the fracture pattern and topography of the tubing ends from the sample devices was compared to the event device.They were found to be noticeably different.A sharp instrument was then used to nick the surface of a returned sample and pull testing was once again performed.After separation, the cross-sectional surfaces of the tubing were again visually compared to the event device.The topography and fracture patterns were found to be similar.Manufacturing records for all of the potentially affected lots were reviewed, but no anomalies were identified.The root cause of the event could not be conclusively identified, but medtronic¿s quality engineers confirmed that there have not been any similar occurrences reported for this product line over the last year.(b)(4).

• Brand Name: DLP LEFT ATRIAL PRESSURE MONITORING CATHETER
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): PERFUSION SYSTEMS; 7611 northland dr; brooklyn park MN 55428
• Manufacturer (Section G): MEDTRONIC STRUCTURAL HEART; 8200 coral sea street ne; mounds view MN 55112
• Manufacturer Contact: paula bixby ; 8200 coral sea street ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 3907393
• MDR Text Key: 4580991
• Report Number: 2184009-2014-00046
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K841482
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 09/19/2014

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 50010
• Device Catalogue Number: 50010
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/16/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/19/2014
• Initial Date FDA Received: 07/01/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Life Threatening; Required Intervention