MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. CATH PKGD: THEMISTOR 7.5 110CM; BALLOON THERMODILUTION CATHETER

Catalog Number AI-07077-G

Device Problems No Device Output (1435); Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2014

Event Type  malfunction  

Event Description

It was reported that the event occurred while in the intensive care unit during insertion and during use of an ai-07077-g inserted via a vascular access.On (b)(6) 2014, during the shift, it was not possible to do hemodynamics; they tried to reposition the catheter unsuccessfully and were not able to perform the measurement.On (b)(6) 2014 they tried again to perform the measurements and it didn't show an acceptable pressure curve for pulmonary wedge.The physician states that the catheter is too rigid and doesn't allow an easy manipulation.When shooting the cardiac output, saline solution is injected and the monitor shows no curve at all.They did several attempts, the monitor cables were changed and still no curve appeared.As a result, the shift's physician ordered the withdrawal of the catheter.The md made the medical judgement that there was no report of patient death, complications or injury.There was not a delay or interruption in therapy with no harm to the patient noted.There was no medical or surgical intervention required.They did not insert another catheter.The patient outcome was stable.

Manufacturer Narrative

(b)(4).

• Brand Name: CATH PKGD: THEMISTOR 7.5 110CM
• Type of Device: BALLOON THERMODILUTION CATHETER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth dr; chelmsford MA 01824
• Manufacturer Contact: anne rosenberger ; 2400 bernville road; reading, PA 19605 ; 6104783117
• MDR Report Key: 4173120
• MDR Text Key: 5020293
• Report Number: 3010532612-2014-00027
• Device Sequence Number: 1
• Product Code: DYG
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K833918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2015
• Device Catalogue Number: AI-07077-G
• Device Lot Number: 16F14E0084
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/19/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1