MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG VALON ELITE BI-CAVAL DUAL LUMEN CATHETER; CATHETER, INTRAVASCULAR, GENERAL-PURPOSE

Device Problems Decrease in Suction (1146); Suction Problem (2170)

Patient Problem Death (1802)

Event Type  Death  

Event Description

Ref imp #(b)(4).

Manufacturer Narrative

(b)(4).Maquet (b)(4) provides product failure investigation, analysis and resolution for the device described in this report.Since the device is not available a technical evaluation cannot be performed.As the lot number is not available a review of production data cannot be performed as well.

• Brand Name: VALON ELITE BI-CAVAL DUAL LUMEN CATHETER
• Type of Device: CATHETER, INTRAVASCULAR, GENERAL-PURPOSE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt 7643 6; GM 76436
• Manufacturer Contact: janice pevide ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097753
• MDR Report Key: 3692472
• MDR Text Key: 4239588
• Report Number: 8010762-2014-00111
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Remedial Action: Other
• Type of Report: Initial

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?: No
• Device Operator: Other
• Initial Date Manufacturer Received: 02/17/2014
• Initial Date FDA Received: 03/05/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1